Clinical trial NCT02451137: A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)
Official title: A Randomized, Open-label, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes of Toujeo Compared to Commercially Available Basal Insulins for Initiation of Therapy in Insulin-naive Patients With Uncontrolled Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-05-21
Enrollment: 3304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets (\<8% if age \>=65 years or with defined comorbidities or otherwise \<7%) at 6 months without documented symptomatic (Blood Glucose \<=70 mg/deciliter \[mg/dL\]) and/or severe hypoglycemia at any time of day from baseline to 6 months in uncontrolled insulin naive participants with type 2 diabetes initiating basal insulin therapy in a real world setting.

Secondary Objectives:

Compare Toujeo to other commercially available basal insulins at 6 months after initiating insulin therapy in a real world setting in terms of:

* Participant persistence with assigned basal insulin therapy.
* Risk of hypoglycemia including the incidence and rate of documented symptomatic and severe hypoglycemia.
* Changes in HbA1c, fasting plasma glucose, body weight
* Differences in participant and provider- reported outcomes (including Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs) and (DTSQc), Hypoglycemia Patient Questionnaire, and participant and provider reported Global Effectiveness Scale (GES).
* Healthcare resource utilization including hospitalizations and emergency department or other provider visits and healthcare costs.

Detailed description: The total study duration per patient will be up to 53 weeks, consisting of a 1-week screening period at the site, a 26-week treatment period, and a 26-week extension period.

Eligibility criteria: Inclusion criteria :

* Participants with Type 2 Diabetes Mellitus (T2DM), as defined by the American Diabetes Association/World Health Organization, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled after at least 1 year of treatment with 2 or more of the following: oral agents (metformin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 (DPP4) inhibitors, or sodium-glucose cotransporter 2 (SGLT2) inhibitors) or glucagon-like peptide-1 (GLP-1) receptor agonists approved for daily use with insulin (Victoza, Byetta, Adlyxin).
* Adult patients who have signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.

Exclusion criteria:

* HbA1c \<8.0% or \>11.0%.
* Males or females \<18 years of age.
* Type 1 diabetes mellitus.
* Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the participant's successful participation for the duration of the study.
* Use of any product containing insulin (Lantus, Levemir, Humulin, Novolin, Humalog, Novolog, Apidra, or Afrezza) since the time of diagnosis with T2DM other than temporary use during pregnancy or hospitalization, or short-term use during acute event.
* Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists for weekly use, or any investigational agent (drug, biologic, or device) within 3 months prior to the time of screening.
* All contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective national product labeling for these products.
* Pregnancy or lactation.
* Women of childbearing potential with no effective contraceptive method.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia
timeFrame: Baseline to Month 6
Secondary outcomes:
measure: Change From Baseline in HbA1c at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Treatment Persistence Measured by Medication Possession Ratio (MPR)
timeFrame: At Month 6 and Month 12
measure: Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <3.0 mmol/L (<54 mg/dL) and/or Severe Hypoglycemia During the 6-Month Randomized Period
timeFrame: Baseline to Month 6
measure: Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <=3.9 mmol/L (<= 70 mg/dL) and <3.0 mmol/L (< 54 mg/dL) and/or Severe Hypoglycemia During the 12-Month Randomized Period
timeFrame: Baseline to Month 12
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Change From Baseline in Body Weight at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Change From Baseline in Basal Insulin Dose at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Percentage of Responders (Participants and Provider) Who Reported "Excellent" or "Good" Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12
timeFrame: At Month 6, Month 12
measure: Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12
timeFrame: At Baseline, Month 6, Month 12
measure: Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12
timeFrame: At Month 12
measure: Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12
timeFrame: From Baseline to Month 6 and Month 12
measure: Percentage of Participants With at Least One Treatment-Emergent Hypoglycemia Event (Any Time of the Day, Nocturnal) Per Type of Hypoglycaemia During the Month 6 and Month 12 on Treatment Period
timeFrame: Up to Month 6 and Month 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number 840731
state: Alabama
city: Birmingham
country: United States
facility: Investigational Site Number 840305
state: Alabama
city: Birmingham
country: United States
facility: Investigational Site Number 840811
state: Alabama
city: Gulf Shores
country: United States
facility: Investigational Site Number 840218
state: Alabama
city: Guntersville
country: United States
facility: Investigational Site Number 840739
state: Alabama
city: Huntsville
country: United States
facility: Investigational Site Number 840367
state: Alabama
city: Montgomery
country: United States
facility: Investigational Site Number 840130
state: Alabama
city: Montgomery
country: United States
facility: Investigational Site Number 840729
state: Alabama
city: Saraland
country: United States
facility: Investigational Site Number 840281
state: Alabama
city: Sheffield
country: United States
facility: Investigational Site Number 840613
state: Alabama
city: Sheffield
country: United States
facility: Investigational Site Number 840634
state: Alabama
city: Sheffield
country: United States
facility: Investigational Site Number 840654
state: Alabama
city: Phoenix
country: United States
facility: Investigational Site Number 840173
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840555
state: Arizona
city: Sun City
country: United States
facility: Investigational Site Number 840805
state: Arizona
city: Conway
country: United States
facility: Investigational Site Number 840725
state: Arkansas
city: Jonesboro
country: United States
facility: Investigational Site Number 840790
state: Arkansas
city: Little Rock
country: United States
facility: Investigational Site Number 840699
state: Arkansas
city: Little Rock
country: United States
facility: Investigational Site Number 840528
state: Arkansas
city: Searcy
country: United States
facility: Investigational Site Number 840079
state: Arkansas
city: Bakersfield
country: United States
facility: Investigational Site Number 840337
state: California
city: El Cajon
country: United States
facility: Investigational Site Number 840089
state: California
city: Escondido
country: United States
facility: Investigational Site Number 840024
state: California
city: Fresno
country: United States
facility: Investigational Site Number 840020
state: California
city: Imperial
country: United States
facility: Investigational Site Number 840470
state: California
city: Inglewood
country: United States
facility: Investigational Site Number 840155
state: California
city: Inglewood
country: United States
facility: Investigational Site Number 840161
state: California
city: Laguna Hills
country: United States
facility: Investigational Site Number 840194
state: California
city: Laguna Hills
country: United States
facility: Investigational Site Number 840710
state: California
city: Lancaster
country: United States
facility: Investigational Site Number 840204
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840371
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840310
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840504
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840340
state: California
city: Los Gatos
country: United States
facility: Investigational Site Number 840309
state: California
city: North Hollywood
country: United States
facility: Investigational Site Number 840256
state: California
city: Northridge
country: United States
facility: Investigational Site Number 840015
state: California
city: Norwalk
country: United States
facility: Investigational Site Number 840056
state: California
city: Orange
country: United States
facility: Investigational Site Number 840090
state: California
city: Palm Springs
country: United States
facility: Investigational Site Number 840078
state: California
city: Palmdale
country: United States
facility: Investigational Site Number 840791
state: California
city: Paramount
country: United States
facility: Investigational Site Number 840216
state: California
city: Pomona
country: United States
facility: Investigational Site Number 840413
state: California
city: Port Hueneme
country: United States
facility: Investigational Site Number 840244
state: California
city: San Diego
country: United States
facility: Investigational Site Number 840162
state: California
city: San Diego
country: United States
facility: Investigational Site Number 840028
state: California
city: San Dimas
country: United States
facility: Investigational Site Number 840383
state: California
city: San Jose
country: United States
facility: Investigational Site Number 840627
state: California
city: San Ramon
country: United States
facility: Investigational Site Number 840120
state: California
city: Santa Ana
country: United States
facility: Investigational Site Number 840156
state: California
city: Sherman Oaks
country: United States
facility: Investigational Site Number 840266
state: California
city: Sylmar
country: United States
facility: Investigational Site Number 840091
state: California
city: Thousand Oaks
country: United States
facility: Investigational Site Number 840208
state: California
city: Torrance
country: United States
facility: Investigational Site Number 840115
state: California
city: Torrance
country: United States
facility: Investigational Site Number 840792
state: California
city: Tulare
country: United States
facility: Investigational Site Number 840612
state: California
city: Upland
country: United States
facility: Investigational Site Number 840467
state: California
city: Vista
country: United States
facility: Investigational Site Number 840185
state: California
city: Whittier
country: United States
facility: Investigational Site Number 840472
state: California
city: Aurora
country: United States
facility: Investigational Site Number 840411
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840596
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840170
state: Colorado
city: Englewood
country: United States
facility: Investigational Site Number 840188
state: Colorado
city: Littleton
country: United States
facility: Investigational Site Number 840329
state: Colorado
city: Littleton
country: United States
facility: Investigational Site Number 840728
state: Colorado
city: Northglenn
country: United States
facility: Investigational Site Number 840687
state: Colorado
city: Aventura
country: United States
facility: Investigational Site Number 840643
state: Florida
city: Boca Raton
country: United States
facility: Investigational Site Number 840652
state: Florida
city: Bradenton
country: United States
facility: Investigational Site Number 840449
state: Florida
city: Cooper City
country: United States
facility: Investigational Site Number 840081
state: Florida
city: Coral Gables
country: United States
facility: Investigational Site Number 840027
state: Florida
city: Coral Gables
country: United States
facility: Investigational Site Number 840446
state: Florida
city: Cutler Bay
country: United States
facility: Investigational Site Number 840407
state: Florida
city: Doral
country: United States
facility: Investigational Site Number 840083
state: Florida
city: Fleming Island
country: United States
facility: Investigational Site Number 840141
state: Florida
city: Fort Lauderdale
country: United States
facility: Investigational Site Number 840035
state: Florida
city: Fort Lauderdale
country: United States
facility: Investigational Site Number 840068
state: Florida
city: Hialeah
country: United States
facility: Investigational Site Number 840145
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840142
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840352
state: Florida
city: Jupiter
country: United States
facility: Investigational Site Number 840021
state: Florida
city: Kissimmee
country: United States
facility: Investigational Site Number 840639
state: Florida
city: Kissimmee
country: United States
facility: Investigational Site Number 840640
state: Florida
city: Lake Clarke Shores
country: United States
facility: Investigational Site Number 840777
state: Florida
city: Margate
country: United States
facility: Investigational Site Number 840362
state: Florida
city: Miami Lakes
country: United States
facility: Investigational Site Number 840221
state: Florida
city: Miami Lakes
country: United States
facility: Investigational Site Number 840303
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840002
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840012
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840698
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840102
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840209
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840014
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840128
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840143
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840349
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840758
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840690
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840415
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840197
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840414
state: Florida
city: Ocala
country: United States
facility: Investigational Site Number 840508
state: Florida
city: Ocoee
country: United States
facility: Investigational Site Number 840092
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 840118
state: Florida
city: Panama City
country: United States
facility: Investigational Site Number 840080
state: Florida
city: Plantation
country: United States
facility: Investigational Site Number 840372
state: Florida
city: Port Charlotte
country: United States
facility: Investigational Site Number 840199
state: Florida
city: Winter Haven
country: United States
facility: Investigational Site Number 840538
state: Florida
city: Atlanta
country: United States
facility: Investigational Site Number 840261
state: Georgia
city: Atlanta
country: United States
facility: Investigational Site Number 840232
state: Georgia
city: Blue Ridge
country: United States
facility: Investigational Site Number 840129
state: Georgia
city: Columbus
country: United States
facility: Investigational Site Number 840820
state: Georgia
city: Decatur
country: United States
facility: Investigational Site Number 840767
state: Georgia
city: Decatur
country: United States
facility: Investigational Site Number 840812
state: Georgia
city: Dunwoody
country: United States
facility: Investigational Site Number 840700
state: Georgia
city: East Point
country: United States
facility: Investigational Site Number 840648
state: Georgia
city: Lawrenceville
country: United States
facility: Investigational Site Number 840110
state: Georgia
city: Macon
country: United States
facility: Investigational Site Number 840444
state: Georgia
city: Marietta
country: United States
facility: Investigational Site Number 840003
state: Georgia
city: Sandersville
country: United States
facility: Investigational Site Number 840632
state: Georgia
city: Savannah
country: United States
facility: Investigational Site Number 840616
state: Georgia
city: Savannah
country: United States
facility: Investigational Site Number 840591
state: Georgia
city: Smyrna
country: United States
facility: Investigational Site Number 840727
state: Georgia
city: Snellville
country: United States
facility: Investigational Site Number 840520
state: Georgia
city: Statesboro
country: United States
facility: Investigational Site Number 840163
state: Georgia
city: Stockbridge
country: United States
facility: Investigational Site Number 840297
state: Georgia
city: Thomson
country: United States
facility: Investigational Site Number 840715
state: Georgia
city: Blackfoot
country: United States
facility: Investigational Site Number 840400
state: Idaho
city: Boise
country: United States
facility: Investigational Site Number 840764
state: Idaho
city: Chicago
country: United States
facility: Investigational Site Number 840005
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840399
state: Illinois
city: Elgin
country: United States
facility: Investigational Site Number 840301
state: Illinois
city: Joliet
country: United States
facility: Investigational Site Number 840402
state: Illinois
city: Morton
country: United States
facility: Investigational Site Number 840226
state: Illinois
city: Peoria
country: United States
facility: Investigational Site Number 840318
state: Illinois
city: Avon
country: United States
facility: Investigational Site Number 840125
state: Indiana
city: Brownsburg
country: United States
facility: Investigational Site Number 840344
state: Indiana
city: Evansville
country: United States
facility: Investigational Site Number 840007
state: Indiana
city: Evansville
country: United States
facility: Investigational Site Number 840164
state: Indiana
city: Evansville
country: United States
facility: Investigational Site Number 840324
state: Indiana
city: Franklin
country: United States
facility: Investigational Site Number 840022
state: Indiana
city: Greenfield
country: United States
facility: Investigational Site Number 840536
state: Indiana
city: Indianapolis
country: United States
facility: Investigational Site Number 840582
state: Indiana
city: Michigan City
country: United States
facility: Investigational Site Number 840694
state: Indiana
city: Muncie
country: United States
facility: Investigational Site Number 840052
state: Indiana
city: New Albany
country: United States
facility: Investigational Site Number 840786
state: Indiana
city: Council Bluffs
country: United States
facility: Investigational Site Number 840686
state: Iowa
city: Des Moines
country: United States
facility: Investigational Site Number 840175
state: Iowa
city: West Des Moines
country: United States
facility: Investigational Site Number 840466
state: Iowa
city: Topeka
country: United States
facility: Investigational Site Number 840134
state: Kansas
city: Ashland
country: United States
facility: Investigational Site Number 840801
state: Kentucky
city: Benton
country: United States
facility: Investigational Site Number 840754
state: Kentucky
city: Covington
country: United States
facility: Investigational Site Number 840342
state: Kentucky
city: Elizabethtown
country: United States
facility: Investigational Site Number 840713
state: Kentucky
city: Hopkinsville
country: United States
facility: Investigational Site Number 840681
state: Kentucky
city: Louisville
country: United States
facility: Investigational Site Number 840578
state: Kentucky
city: Owensboro
country: United States
facility: Investigational Site Number 840478
state: Kentucky
city: Owensboro
country: United States
facility: Investigational Site Number 840576
state: Kentucky
city: Owensboro
country: United States
facility: Investigational Site Number 840819
state: Kentucky
city: Paris
country: United States
facility: Investigational Site Number 840645
state: Kentucky
city: Versailles
country: United States
facility: Investigational Site Number 840741
state: Kentucky
city: Covington
country: United States
facility: Investigational Site Number 840592
state: Louisiana
city: Covington
country: United States
facility: Investigational Site Number 840744
state: Louisiana
city: Crowley
country: United States
facility: Investigational Site Number 840532
state: Louisiana
city: Hammond
country: United States
facility: Investigational Site Number 840760
state: Louisiana
city: Lake Charles
country: United States
facility: Investigational Site Number 840463
state: Louisiana
city: Marrero
country: United States
facility: Investigational Site Number 840675
state: Louisiana
city: Metairie
country: United States
facility: Investigational Site Number 840133
state: Louisiana
city: Monroe
country: United States
facility: Investigational Site Number 840622
state: Louisiana
city: Natchitoches
country: United States
facility: Investigational Site Number 840147
state: Louisiana
city: New Orleans
country: United States
facility: Investigational Site Number 840609
state: Louisiana
city: Shreveport
country: United States
facility: Investigational Site Number 840311
state: Louisiana
city: Slidell
country: United States
facility: Investigational Site Number 840619
state: Louisiana
city: Zachary
country: United States
facility: Investigational Site Number 840673
state: Louisiana
city: Bangor
country: United States
facility: Investigational Site Number 840387
state: Maine
city: Portland
country: United States
facility: Investigational Site Number 840689
state: Maine
city: Baltimore
country: United States
facility: Investigational Site Number 840534
state: Maryland
city: Catonsville
country: United States
facility: Investigational Site Number 840455
state: Maryland
city: Rockville
country: United States
facility: Investigational Site Number 840393
state: Maryland
city: Boston
country: United States
facility: Investigational Site Number 840423
state: Massachusetts
city: Alpena
country: United States
facility: Investigational Site Number 840117
state: Michigan
city: Detroit
country: United States
facility: Investigational Site Number 840289
state: Michigan
city: Essexville
country: United States
facility: Investigational Site Number 840053
state: Michigan
city: Flint
country: United States
facility: Investigational Site Number 840150
state: Michigan
city: Flint
country: United States
facility: Investigational Site Number 840184
state: Michigan
city: Kalamazoo
country: United States
facility: Investigational Site Number 840236
state: Michigan
city: Southfield
country: United States
facility: Investigational Site Number 840210
state: Michigan
city: Stevensville
country: United States
facility: Investigational Site Number 840258
state: Michigan
city: Troy
country: United States
facility: Investigational Site Number 840158
state: Michigan
city: Troy
country: United States
facility: Investigational Site Number 840524
state: Michigan
city: Olive Branch
country: United States
facility: Investigational Site Number 840033
state: Mississippi
city: Bridgeton
country: United States
facility: Investigational Site Number 840302
state: Missouri
city: Chesterfield
country: United States
facility: Investigational Site Number 840693
state: Missouri
city: Jefferson City
country: United States
facility: Investigational Site Number 840041
state: Missouri
city: Saint Louis
country: United States
facility: Investigational Site Number 840711
state: Missouri
city: Billings
country: United States
facility: Investigational Site Number 840753
state: Montana
city: Butte
country: United States
facility: Investigational Site Number 840603
state: Montana
city: Elkhorn
country: United States
facility: Investigational Site Number 840264
state: Nebraska
city: Omaha
country: United States
facility: Investigational Site Number 840742
state: Nebraska
city: Henderson
country: United States
facility: Investigational Site Number 840294
state: Nevada
city: Henderson
country: United States
facility: Investigational Site Number 840087
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840664
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840108
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840412
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840656
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840638
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840750
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840815
state: Nevada
city: Reno
country: United States
facility: Investigational Site Number 840761
state: Nevada
city: Nashua
country: United States
facility: Investigational Site Number 840144
state: New Hampshire
city: Edison
country: United States
facility: Investigational Site Number 840799
state: New Jersey
city: Linden
country: United States
facility: Investigational Site Number 840167
state: New Jersey
city: Neptune
country: United States
facility: Investigational Site Number 840060
state: New Jersey
city: Sicklerville
country: United States
facility: Investigational Site Number 840679
state: New Jersey
city: Teaneck
country: United States
facility: Investigational Site Number 840559
state: New Jersey
city: Albany
country: United States
facility: Investigational Site Number 840481
state: New York
city: Amityville
country: United States
facility: Investigational Site Number 840772
state: New York
city: Babylon
country: United States
facility: Investigational Site Number 840746
state: New York
city: Brooklyn
country: United States
facility: Investigational Site Number 840355
state: New York
city: Brooklyn
country: United States
facility: Investigational Site Number 840136
state: New York
city: Forest Hills
country: United States
facility: Investigational Site Number 840734
state: New York
city: Great Neck
country: United States
facility: Investigational Site Number 840659
state: New York
city: Holbrook
country: United States
facility: Investigational Site Number 840644
state: New York
city: Jamaica
country: United States
facility: Investigational Site Number 840159
state: New York
city: Lake Success
country: United States
facility: Investigational Site Number 840148
state: New York
city: Laurelton
country: United States
facility: Investigational Site Number 840253
state: New York
city: Merrick
country: United States
facility: Investigational Site Number 840789
state: New York
city: Nesconset
country: United States
facility: Investigational Site Number 840716
state: New York
city: New Hyde Park
country: United States
facility: Investigational Site Number 840810
state: New York
city: New Hyde Park
country: United States
facility: Investigational Site Number 840072
state: New York
city: New Windsor
country: United States
facility: Investigational Site Number 840674
state: New York
city: New York
country: United States
facility: Investigational Site Number 840626
state: New York
city: New York
country: United States
facility: Investigational Site Number 840586
state: New York
city: North Massapequa
country: United States
facility: Investigational Site Number 840044
state: New York
city: Smithtown
country: United States
facility: Investigational Site Number 840587
state: New York
city: Staten Island
country: United States
facility: Investigational Site Number 840577
state: New York
city: Syosset
country: United States
facility: Investigational Site Number 840773
state: New York
city: Yonkers
country: United States
facility: Investigational Site Number 840047
state: New York
city: Asheville
country: United States
facility: Investigational Site Number 840214
state: North Carolina
city: Burlington
country: United States
facility: Investigational Site Number 840237
state: North Carolina
city: Burlington
country: United States
facility: Investigational Site Number 840714
state: North Carolina
city: Charlotte
country: United States
facility: Investigational Site Number 840456
state: North Carolina
city: Concord
country: United States
facility: Investigational Site Number 840312
state: North Carolina
city: Greensboro
country: United States
facility: Investigational Site Number 840763
state: North Carolina
city: Greensboro
country: United States
facility: Investigational Site Number 840611
state: North Carolina
city: Greensboro
country: United States
facility: Investigational Site Number 840776
state: North Carolina
city: Greenville
country: United States
facility: Investigational Site Number 840361
state: North Carolina
city: High Point
country: United States
facility: Investigational Site Number 840705
state: North Carolina
city: Lexington
country: United States
facility: Investigational Site Number 840755
state: North Carolina
city: Mooresville
country: United States
facility: Investigational Site Number 840688
state: North Carolina
city: Mooresville
country: United States
facility: Investigational Site Number 840747
state: North Carolina
city: Morganton
country: United States
facility: Investigational Site Number 840296
state: North Carolina
city: New Bern
country: United States
facility: Investigational Site Number 840573
state: North Carolina
city: Salisbury
country: United States
facility: Investigational Site Number 840096
state: North Carolina
city: Shelby
country: United States
facility: Investigational Site Number 840697
state: North Carolina
city: Wilmington
country: United States
facility: Investigational Site Number 840636
state: North Carolina
city: Wilson
country: United States
facility: Investigational Site Number 840195
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigational Site Number 840315
state: North Carolina
city: Fargo
country: United States
facility: Investigational Site Number 840545
state: North Dakota
city: Canal Fulton
country: United States
facility: Investigational Site Number 840077
state: Ohio
city: Canton
country: United States
facility: Investigational Site Number 840738
state: Ohio
city: Cincinnati
country: United States
facility: Investigational Site Number 840064
state: Ohio
city: Cincinnati
country: United States
facility: Investigational Site Number 840701
state: Ohio
city: Cleveland
country: United States
facility: Investigational Site Number 840779
state: Ohio
city: Columbus
country: United States
facility: Investigational Site Number 840380
state: Ohio
city: Columbus
country: United States
facility: Investigational Site Number 840339
state: Ohio
city: Columbus
country: United States
facility: Investigational Site Number 840063
state: Ohio
city: Columbus
country: United States
facility: Investigational Site Number 840191
state: Ohio
city: Columbus
country: United States
facility: Investigational Site Number 840752
state: Ohio
city: Elyria
country: United States
facility: Investigational Site Number 840684
state: Ohio
city: Findlay
country: United States
facility: Investigational Site Number 840663
state: Ohio
city: Franklin
country: United States
facility: Investigational Site Number 840379
state: Ohio
city: Gallipolis
country: United States
facility: Investigational Site Number 840126
state: Ohio
city: Kettering
country: United States
facility: Investigational Site Number 840771
state: Ohio
city: Lancaster
country: United States
facility: Investigational Site Number 840257
state: Ohio
city: Lyndhurst
country: United States
facility: Investigational Site Number 840584
state: Ohio
city: Marion
country: United States
facility: Investigational Site Number 840165
state: Ohio
city: Miamisburg
country: United States
facility: Investigational Site Number 840800
state: Ohio
city: Tallmadge
country: United States
facility: Investigational Site Number 840560
state: Ohio
city: Toledo
country: United States
facility: Investigational Site Number 840515
state: Ohio
city: Vandalia
country: United States
facility: Investigational Site Number 840797
state: Ohio
city: Wadsworth
country: United States
facility: Investigational Site Number 840192
state: Ohio
city: Willoughby Hills
country: United States
facility: Investigational Site Number 840389
state: Ohio
city: Wooster
country: United States
facility: Investigational Site Number 840751
state: Ohio
city: Edmond
country: United States
facility: Investigational Site Number 840262
state: Oklahoma
city: Midwest City
country: United States
facility: Investigational Site Number 840360
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigational Site Number 840363
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigational Site Number 840556
state: Oklahoma
city: Bend
country: United States
facility: Investigational Site Number 840103
state: Oregon
city: Altoona
country: United States
facility: Investigational Site Number 840292
state: Pennsylvania
city: Beaver
country: United States
facility: Investigational Site Number 840009
state: Pennsylvania
city: Downingtown
country: United States
facility: Investigational Site Number 840059
state: Pennsylvania
city: Fleetwood
country: United States
facility: Investigational Site Number 840181
state: Pennsylvania
city: Greensburg
country: United States
facility: Investigational Site Number 840743
state: Pennsylvania
city: Huntingdon Valley
country: United States
facility: Investigational Site Number 840479
state: Pennsylvania
city: Indiana
country: United States
facility: Investigational Site Number 840712
state: Pennsylvania
city: Lansdale
country: United States
facility: Investigational Site Number 840523
state: Pennsylvania
city: Levittown
country: United States
facility: Investigational Site Number 840766
state: Pennsylvania
city: Penndel
country: United States
facility: Investigational Site Number 840032
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Site Number 840067
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Site Number 840277
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Site Number 840561
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Site Number 840174
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site Number 840348
state: Pennsylvania
city: Pottstown
country: United States
facility: Investigational Site Number 840669
state: Pennsylvania
city: Sayre
country: United States
facility: Investigational Site Number 840748
state: Pennsylvania
city: Smithfield
country: United States
facility: Investigational Site Number 840187
state: Pennsylvania
city: Uniontown
country: United States
facility: Investigational Site Number 840287
state: Pennsylvania
city: Uniontown
country: United States
facility: Investigational Site Number 840341
state: Pennsylvania
city: Providence
country: United States
facility: Investigational Site Number 840378
state: Rhode Island
city: Anderson
country: United States
facility: Investigational Site Number 840491
state: South Carolina
city: Greenville
country: United States
facility: Investigational Site Number 840732
state: South Carolina
city: Greer
country: United States
facility: Investigational Site Number 840043
state: South Carolina
city: Murrells Inlet
country: United States
facility: Investigational Site Number 840109
state: South Carolina
city: North Myrtle Beach
country: United States
facility: Investigational Site Number 840327
state: South Carolina
city: Simpsonville
country: United States
facility: Investigational Site Number 840759
state: South Carolina
city: Summerville
country: United States
facility: Investigational Site Number 840628
state: South Carolina
city: Bristol
country: United States
facility: Investigational Site Number 840717
state: Tennessee
city: Chattanooga
country: United States
facility: Investigational Site Number 840160
state: Tennessee
city: Franklin
country: United States
facility: Investigational Site Number 840794
state: Tennessee
city: Jackson
country: United States
facility: Investigational Site Number 840171
state: Tennessee
city: Jackson
country: United States
facility: Investigational Site Number 840550
state: Tennessee
city: Kingsport
country: United States
facility: Investigational Site Number 840132
state: Tennessee
city: Knoxville
country: United States
facility: Investigational Site Number 840140
state: Tennessee
city: Memphis
country: United States
facility: Investigational Site Number 840625
state: Tennessee
city: Nashville
country: United States
facility: Investigational Site Number 840299
state: Tennessee
city: New Tazewell
country: United States
facility: Investigational Site Number 840381
state: Tennessee
city: Amarillo
country: United States
facility: Investigational Site Number 840213
state: Texas
city: Corpus Christi
country: United States
facility: Investigational Site Number 840157
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840011
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840313
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840013
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840034
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840333
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840405
state: Texas
city: El Paso
country: United States
facility: Investigational Site Number 840330
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number 840307
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840182
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840366
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840608
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840323
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840502
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840513
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840377
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840306
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840137
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840521
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840533
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840211
state: Texas
city: Humble
country: United States
facility: Investigational Site Number 840260
state: Texas
city: Irving
country: United States
facility: Investigational Site Number 840403
state: Texas
city: Lampasas
country: United States
facility: Investigational Site Number 840382
state: Texas
city: Lubbock
country: United States
facility: Investigational Site Number 840680
state: Texas
city: McAllen
country: United States
facility: Investigational Site Number 840308
state: Texas
city: Mesquite
country: United States
facility: Investigational Site Number 840549
state: Texas
city: Missouri City
country: United States
facility: Investigational Site Number 840351
state: Texas
city: Palestine
country: United States
facility: Investigational Site Number 840373
state: Texas
city: Pharr
country: United States
facility: Investigational Site Number 840365
state: Texas
city: Plano
country: United States
facility: Investigational Site Number 840439
state: Texas
city: Port Arthur
country: United States
facility: Investigational Site Number 840707
state: Texas
city: Richmond
country: United States
facility: Investigational Site Number 840692
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840431
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840074
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840691
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840176
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840135
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840018
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840434
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840390
state: Texas
city: Schertz
country: United States
facility: Investigational Site Number 840207
state: Texas
city: Sealy
country: United States
facility: Investigational Site Number 840615
state: Texas
city: Sugar Land
country: United States
facility: Investigational Site Number 840097
state: Texas
city: Sugar Land
country: United States
facility: Investigational Site Number 840460
state: Texas
city: Sugar Land
country: United States
facility: Investigational Site Number 840514
state: Texas
city: Sugar Land
country: United States
facility: Investigational Site Number 840530
state: Texas
city: Waco
country: United States
facility: Investigational Site Number 840008
state: Texas
city: Waco
country: United States
facility: Investigational Site Number 840593
state: Texas
city: Waxahachie
country: United States
facility: Investigational Site Number 840809
state: Texas
city: Webster
country: United States
facility: Investigational Site Number 840651
state: Texas
city: Clinton
country: United States
facility: Investigational Site Number 840392
state: Utah
city: Saint George
country: United States
facility: Investigational Site Number 840189
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site Number 840228
state: Utah
city: West Jordan
country: United States
facility: Investigational Site Number 840765
state: Utah
city: West Jordan
country: United States
facility: Investigational Site Number 840806
state: Utah
city: Chatham
country: United States
facility: Investigational Site Number 840580
state: Virginia
city: Chesapeake
country: United States
facility: Investigational Site Number 840590
state: Virginia
city: Danville
country: United States
facility: Investigational Site Number 840788
state: Virginia
city: Danville
country: United States
facility: Investigational Site Number 840706
state: Virginia
city: Danville
country: United States
facility: Investigational Site Number 840736
state: Virginia
city: Fredericksburg
country: United States
facility: Investigational Site Number 840575
state: Virginia
city: Hampton
country: United States
facility: Investigational Site Number 840662
state: Virginia
city: Lynchburg
country: United States
facility: Investigational Site Number 840795
state: Virginia
city: Martinsville
country: United States
facility: Investigational Site Number 840605
state: Virginia
city: Newport News
country: United States
facility: Investigational Site Number 840620
state: Virginia
city: Norfolk
country: United States
facility: Investigational Site Number 840088
state: Virginia
city: North Chesterfield
country: United States
facility: Investigational Site Number 840247
state: Virginia
city: Pennington Gap
country: United States
facility: Investigational Site Number 840730
state: Virginia
city: Richmond
country: United States
facility: Investigational Site Number 840179
state: Virginia
city: Salem
country: United States
facility: Investigational Site Number 840076
state: Virginia
city: Virginia Beach
country: United States
facility: Investigational Site Number 840354
state: Virginia
city: Winchester
country: United States
facility: Investigational Site Number 840704
state: Virginia
city: Everett
country: United States
facility: Investigational Site Number 840709
state: Washington
city: Federal Way
country: United States
facility: Investigational Site Number 840238
state: Washington
city: Vancouver
country: United States
facility: Investigational Site Number 840588
state: Washington
city: Walla Walla
country: United States
facility: Investigational Site Number 840084
state: Washington
city: Charleston
country: United States
facility: Investigational Site Number 840658
state: West Virginia
city: Lewisburg
country: United States
facility: Investigational Site Number 840595
state: West Virginia
city: Barrie
country: Canada
facility: Investigational Site Number 124002
city: Brampton
country: Canada
facility: Investigational Site Number 124005
city: Brampton
country: Canada
facility: Investigational Site Number 124001
city: Burlington
country: Canada
facility: Investigational Site Number 124030
city: Calgary
country: Canada
facility: Investigational Site Number 124017
city: Concord
country: Canada
facility: Investigational Site Number 124013
city: Etobicoke
country: Canada
facility: Investigational Site Number 124018
city: Etobicoke
country: Canada
facility: Investigational Site Number 124014
city: Guelph
country: Canada
facility: Investigational Site Number 124026
city: Hamilton
country: Canada
facility: Investigational Site Number 124008
city: Hamilton
country: Canada
facility: Investigational Site Number 124027
city: London
country: Canada
facility: Investigational Site Number 124010
city: Markham
country: Canada
facility: Investigational Site Number 124015
city: Montreal
country: Canada
facility: Investigational Site Number 124020
city: Newmarket
country: Canada
facility: Investigational Site Number 124016
city: Oakville
country: Canada
facility: Investigational Site Number 124024
city: Saint-Laurent
country: Canada
facility: Investigational Site Number 124029
city: Surrey
country: Canada
facility: Investigational Site Number 124007
city: Toronto
country: Canada
facility: Investigational Site Number 124003
city: Vancouver
country: Canada
facility: Investigational Site Number 124025
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Anderson J, Meneghini L, Hinnen D, Gill J, Coudert M, Evenou P, Munshi M. Target attainment in insulin-naive patients at high risk for hypoglycemia: Results from ACHIEVE Control. J Diabetes Complications. 2021 Apr;35(4):107831. doi: 10.1016/j.jdiacomp.2020.107831. Epub 2020 Dec 31.
citation: Oster G, Sullivan SD, Dalal MR, Kazemi MR, Rojeski M, Wysham CH, Sung J, Johnstone B, Cali AM, Wei LJ, Traylor L, Anhalt H, Hull M, Van Vleet J, Meneghini LF. Achieve control: a pragmatic clinical trial of insulin glargine 300 U/mL versus other basal insulins in insulin-naive patients with type 2 diabetes. Postgrad Med. 2016 Nov;128(8):731-739. doi: 10.1080/00325481.2016.1241663. Epub 2016 Oct 24.