Clinical trial NCT01499082: Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin
Official title: 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 807
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:

* To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus

Secondary Objectives:

* To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia

Detailed description: The maximum study duration was up to approximately 58 weeks per participant, consisting of:

* up to 2 week screening period
* 6-month comparative efficacy and safety treatment period
* 6-month comparative safety extension period
* 4-week safety follow-up period in a subset of participants
* a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300

Eligibility criteria: Inclusion criteria :

* Participants with type 2 diabetes mellitus
* Substudy inclusion criteria:

  * Completion of the 6-month study period in main study (Visit 10)
  * Randomized and treated with insulin glargine new formulation during the 6-month treatment period (Baseline - month 6)

Exclusion criteria:

* Age less than (\<) 18 years
* HbA1c \<7.0% or greater than (\>) 10% at screening
* Diabetes other than type 2 diabetes mellitus
* Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose
* Any contraindication to use of insulin glargine as defined in the national product label
* Participants using human regular insulin as mealtime insulin in the last 3 months before screening visit
* Use of an insulin pump in the last 6 months before screening visit
* Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit
* History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
* Pregnant or breast-feeding women or women who intend to become pregnant during the study period
* Substudy exclusion criteria:

  * Participant not willing to use the adaptable injection intervals on at least two days per week

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

Primary outcomes:
measure: Change in HbA1c From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint
timeFrame: Week 9 Up to Month 6
measure: Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Percentage of Participants With HbA1c <7% at Month 6 Endpoint
timeFrame: Month 6
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint
timeFrame: Month 6
measure: Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12
timeFrame: Up to Month 12
Other outcomes:
measure: Change in HbA1c From Month 6 to Month 9
timeFrame: Month 6 Up to Month 9
Locations:
city: Chandler
country: United States
facility: Investigational Site Number 840156
state: Arizona
city: Glendale
country: United States
facility: Investigational Site Number 840102
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840071
state: Arizona
city: Sun City
country: United States
facility: Investigational Site Number 840121
state: Arizona
city: Tempe
country: United States
facility: Investigational Site Number 840070
state: Arizona
city: Hot Springs
country: United States
facility: Investigational Site Number 840016
state: Arkansas
city: Little Rock
country: United States
facility: Investigational Site Number 840015
state: Arkansas
city: Little Rock
country: United States
facility: Investigational Site Number 840124
state: Arkansas
city: Searcy
country: United States
facility: Investigational Site Number 840032
state: Arkansas
city: Anaheim
country: United States
facility: Investigational Site Number 840076
state: California
city: Encino
country: United States
facility: Investigational Site Number 840133
state: California
city: Greenbrae
country: United States
facility: Investigational Site Number 840062
state: California
city: Huntington Beach
country: United States
facility: Investigational Site Number 840057
state: California
city: La Jolla
country: United States
facility: Investigational Site Number 840059
state: California
city: La Mesa
country: United States
facility: Investigational Site Number 840004
state: California
city: Mission Hills
country: United States
facility: Investigational Site Number 840099
state: California
city: Palm Springs
country: United States
facility: Investigational Site Number 840107
state: California
city: San Diego
country: United States
facility: Investigational Site Number 840005
state: California
city: Tustin
country: United States
facility: Investigational Site Number 840013
state: California
city: Walnut Creek
country: United States
facility: Investigational Site Number 840002
state: California
city: Colorado Springs
country: United States
facility: Investigational Site Number 840114
state: Colorado
city: Colorado Springs
country: United States
facility: Investigational Site Number 840136
state: Colorado
city: Longmont
country: United States
facility: Investigational Site Number 840092
state: Colorado
city: Daytona Beach
country: United States
facility: Investigational Site Number 840049
state: Florida
city: Hollywood
country: United States
facility: Investigational Site Number 840050
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840086
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840011
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840009
state: Florida
city: New Port Richey
country: United States
facility: Investigational Site Number 840023
state: Florida
city: Ocoee
country: United States
facility: Investigational Site Number 840012
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 840148
state: Florida
city: Lawrenceville
country: United States
facility: Investigational Site Number 840055
state: Georgia
city: Idaho Falls
country: United States
facility: Investigational Site Number 840052
state: Idaho
city: Nampa
country: United States
facility: Investigational Site Number 840117
state: Idaho
city: McHenry
country: United States
facility: Investigational Site Number 840020
state: Illinois
city: Springfield
country: United States
facility: Investigational Site Number 840019
state: Illinois
city: Avon
country: United States
facility: Investigational Site Number 840078
state: Indiana
city: Avon
country: United States
facility: Investigational Site Number 840089
state: Indiana
city: Avon
country: United States
facility: Investigational Site Number 840097
state: Indiana
city: Avon
country: United States
facility: Investigational Site Number 840098
state: Indiana
city: Avon
country: United States
facility: Investigational Site Number 840100
state: Indiana
city: Vincennes
country: United States
facility: Investigational Site Number 840127
state: Indiana
city: Des Moines
country: United States
facility: Investigational Site Number 840116
state: Iowa
city: Wichita
country: United States
facility: Investigational Site Number 840003
state: Kansas
city: Lexington
country: United States
facility: Investigational Site Number 840080
state: Kentucky
city: Paducah
country: United States
facility: Investigational Site Number 840042
state: Kentucky
city: Baltimore
country: United States
facility: Investigational Site Number 840036
state: Maryland
city: Baltimore
country: United States
facility: Investigational Site Number 840155
state: Maryland
city: Rockville
country: United States
facility: Investigational Site Number 840034
state: Maryland
city: Ann Arbor
country: United States
facility: Investigational Site Number 840065
state: Michigan
city: Dearborn
country: United States
facility: Investigational Site Number 840066
state: Michigan
city: Flint
country: United States
facility: Investigational Site Number 840103
state: Michigan
city: Kalamazoo
country: United States
facility: Investigational Site Number 840126
state: Michigan
city: Southfield
country: United States
facility: Investigational Site Number 840022
state: Michigan
city: Chaska
country: United States
facility: Investigational Site Number 840143
state: Minnesota
city: Eagan
country: United States
facility: Investigational Site Number 840068
state: Minnesota
city: Minneapolis
country: United States
facility: Investigational Site Number 840085
state: Minnesota
city: Kalispell
country: United States
facility: Investigational Site Number 840053
state: Montana
city: Fremont
country: United States
facility: Investigational Site Number 840090
state: Nebraska
city: Omaha
country: United States
facility: Investigational Site Number 840091
state: Nebraska
city: Las Vegas
country: United States
facility: Investigational Site Number 840058
state: Nevada
city: Brick
country: United States
facility: Investigational Site Number 840043
state: New Jersey
city: Toms River
country: United States
facility: Investigational Site Number 840152
state: New Jersey
city: Asheville
country: United States
facility: Investigational Site Number 840146
state: North Carolina
city: Hickory
country: United States
facility: Investigational Site Number 840145
state: North Carolina
city: Wilmington
country: United States
facility: Investigational Site Number 840045
state: North Carolina
city: Fargo
country: United States
facility: Investigational Site Number 840067
state: North Dakota
city: Cincinnati
country: United States
facility: Investigational Site Number 840008
state: Ohio
city: Columbus
country: United States
facility: Investigational Site Number 840106
state: Ohio
city: Dayton
country: United States
facility: Investigational Site Number 840123
state: Ohio
city: Maumee
country: United States
facility: Investigational Site Number 840119
state: Ohio
city: Mentor
country: United States
facility: Investigational Site Number 840122
state: Ohio
city: Medford
country: United States
facility: Investigational Site Number 840083
state: Oregon
city: Portland
country: United States
facility: Investigational Site Number 840084
state: Oregon
city: Uniontown
country: United States
facility: Investigational Site Number 840007
state: Pennsylvania
city: Greer
country: United States
facility: Investigational Site Number 840079
state: South Carolina
city: Rapid City
country: United States
facility: Investigational Site Number 840048
state: South Dakota
city: Chattanooga
country: United States
facility: Investigational Site Number 840039
state: Tennessee
city: Knoxville
country: United States
facility: Investigational Site Number 840159
state: Tennessee
city: Austin
country: United States
facility: Investigational Site Number 840021
state: Texas
city: Austin
country: United States
facility: Investigational Site Number 840129
state: Texas
city: Austin
country: United States
facility: Investigational Site Number 840081
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840001
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840047
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840082
state: Texas
city: Hurst
country: United States
facility: Investigational Site Number 840120
state: Texas
city: Draper
country: United States
facility: Investigational Site Number 840010
state: Utah
city: Ogden
country: United States
facility: Investigational Site Number 840060
state: Utah
city: Chesapeake
country: United States
facility: Investigational Site Number 840035
state: Virginia
city: Norfolk
country: United States
facility: Investigational Site Number 840074
state: Virginia
city: Norfolk
country: United States
facility: Investigational Site Number 840112
state: Virginia
city: Norfolk
country: United States
facility: Investigational Site Number 840041
state: Virginia
city: Richmond
country: United States
facility: Investigational Site Number 840104
state: Virginia
city: Williamsburg
country: United States
facility: Investigational Site Number 840075
state: Virginia
city: Milwaukee
country: United States
facility: Investigational Site Number 840018
state: Wisconsin
city: Beamsville
country: Canada
facility: Investigational Site Number 124024
city: Burlington
country: Canada
facility: Investigational Site Number 124025
city: Calgary
country: Canada
facility: Investigational Site Number 124023
city: Calgary
country: Canada
facility: Investigational Site Number 124020
city: Chatham
country: Canada
facility: Investigational Site Number 124019
city: Coquitlam
country: Canada
facility: Investigational Site Number 124018
city: Hamilton
country: Canada
facility: Investigational Site Number 124021
city: Hamilton
country: Canada
facility: Investigational Site Number 124014
city: Laval
country: Canada
facility: Investigational Site Number 124006
city: London
country: Canada
facility: Investigational Site Number 124009
city: Mississauga
country: Canada
facility: Investigational Site Number 124008
city: Montreal
country: Canada
facility: Investigational Site Number 124015
city: Montreal
country: Canada
facility: Investigational Site Number 124004
city: Oshawa
country: Canada
facility: Investigational Site Number 124005
city: Quebec
country: Canada
facility: Investigational Site Number 124026
city: Red Deer
country: Canada
facility: Investigational Site Number 124002
city: Thornhill
country: Canada
facility: Investigational Site Number 124007
city: Toronto
country: Canada
facility: Investigational Site Number 124001
city: Toronto
country: Canada
facility: Investigational Site Number 124011
city: Victoria
country: Canada
facility: Investigational Site Number 124010
city: Ville St-Laurent
country: Canada
facility: Investigational Site Number 124017
city: Winnipeg
country: Canada
facility: Investigational Site Number 124022
city: Beroun
country: Czechia
facility: Investigational Site Number 203006
city: Breclav
country: Czechia
facility: Investigational Site Number 203001
city: Hodonin
country: Czechia
facility: Investigational Site Number 203002
city: Holesov
country: Czechia
facility: Investigational Site Number 203009
city: Hradec Kralove
country: Czechia
facility: Investigational Site Number 203003
city: Hranice
country: Czechia
facility: Investigational Site Number 203007
city: Krnov
country: Czechia
facility: Investigational Site Number 203004
city: Olomouc
country: Czechia
facility: Investigational Site Number 203010
city: Praha 2
country: Czechia
facility: Investigational Site Number 203008
city: Prostejov
country: Czechia
facility: Investigational Site Number 203005
city: Pärnu
country: Estonia
facility: Investigational Site Number 233002
city: Tallinn
country: Estonia
facility: Investigational Site Number 233004
city: Tallinn
country: Estonia
facility: Investigational Site Number 233006
city: Tallinn
country: Estonia
facility: Investigational Site Number 233003
city: Tallinn
country: Estonia
facility: Investigational Site Number 233001
city: Tartu
country: Estonia
facility: Investigational Site Number 233005
city: Helsinki
country: Finland
facility: Investigational Site Number 246001
city: Kuopio
country: Finland
facility: Investigational Site Number 246005
city: Oulu
country: Finland
facility: Investigational Site Number 246002
city: La Rochelle Cedex
country: France
facility: Investigational Site Number 250004
city: Strasbourg
country: France
facility: Investigational Site Number 250002
city: Heidelberg
country: Germany
facility: Investigational Site Number 276006
city: Riesa
country: Germany
facility: Investigational Site Number 276002
city: Schwabenheim
country: Germany
facility: Investigational Site Number 276003
city: Baja
country: Hungary
facility: Investigational Site Number 348010
city: Balatonfüred
country: Hungary
facility: Investigational Site Number 348004
city: Budapest
country: Hungary
facility: Investigational Site Number 348015
city: Budapest
country: Hungary
facility: Investigational Site Number 348013
city: Budapest
country: Hungary
facility: Investigational Site Number 348017
city: Budapest
country: Hungary
facility: Investigational Site Number 348009
city: Budapest
country: Hungary
facility: Investigational Site Number 348002
city: Debrecen
country: Hungary
facility: Investigational Site Number 348005
city: Eger
country: Hungary
facility: Investigational Site Number 348008
city: Gyula
country: Hungary
facility: Investigational Site Number 348018
city: Makó
country: Hungary
facility: Investigational Site Number 348014
city: Mosonmagyaróvár
country: Hungary
facility: Investigational Site Number 348012
city: Nyiregyháza
country: Hungary
facility: Investigational Site Number 348007
city: Szeged
country: Hungary
facility: Investigational Site Number 348003
city: Szombathely
country: Hungary
facility: Investigational Site Number 348006
city: Sátorlaljaújhely
country: Hungary
facility: Investigational Site Number 348011
city: Zalaegerszeg
country: Hungary
facility: Investigational Site Number 348001
city: Jekabpils
country: Latvia
facility: Investigational Site Number 428006
city: Ogre
country: Latvia
facility: Investigational Site Number 428005
city: Riga
country: Latvia
facility: Investigational Site Number 428002
city: Riga
country: Latvia
facility: Investigational Site Number 428001
city: Riga
country: Latvia
facility: Investigational Site Number 428004
city: Sigulda
country: Latvia
facility: Investigational Site Number 428003
city: Chihuahua
country: Mexico
facility: Investigational Site Number 484007
city: Cuernavaca
country: Mexico
facility: Investigational Site Number 484001
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484006
city: Monterrey
country: Mexico
facility: Investigational Site Number 484003
city: Pachuca
country: Mexico
facility: Investigational Site Number 484004
city: Almelo
country: Netherlands
facility: Investigational Site Number 528009
city: Eindhoven
country: Netherlands
facility: Investigational Site Number 528004
city: Groningen
country: Netherlands
facility: Investigational Site Number 528007
city: Hoogeveen
country: Netherlands
facility: Investigational Site Number 528005
city: Hoorn
country: Netherlands
facility: Investigational Site Number 528001
city: Leeuwarden
country: Netherlands
facility: Investigational Site Number 528008
city: Utrecht
country: Netherlands
facility: Investigational Site Number 528006
city: Venlo
country: Netherlands
facility: Investigational Site Number 528002
city: Bacau
country: Romania
facility: Investigational Site Number 642001
city: Bucuresti
country: Romania
facility: Investigational Site Number 642005
city: Bucuresti
country: Romania
facility: Investigational Site Number 642006
city: Cluj Napoca
country: Romania
facility: Investigational Site Number 642002
city: Iasi
country: Romania
facility: Investigational Site Number 642004
city: Iasi
country: Romania
facility: Investigational Site Number 642008
city: Oradea
country: Romania
facility: Investigational Site Number 642003
city: Targu Mures
country: Romania
facility: Investigational Site Number 642009
city: Timisoara
country: Romania
facility: Investigational Site Number 642007
city: Alberton
country: South Africa
facility: Investigational Site Number 710005
city: Johannesburg
country: South Africa
facility: Investigational Site Number 710003
city: Lenasia
country: South Africa
facility: Investigational Site Number 710006
city: Observatory
country: South Africa
facility: Investigational Site Number 710002
city: Paarl
country: South Africa
facility: Investigational Site Number 710001
city: Pretoria
country: South Africa
facility: Investigational Site Number 710008
city: Somerset West
country: South Africa
facility: Investigational Site Number 710004
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Riddle MC, Bolli GB, Ziemen M, Muehlen-Bartmer I, Bizet F, Home PD; EDITION 1 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014 Oct;37(10):2755-62. doi: 10.2337/dc14-0991. Epub 2014 Jul 30.
citation: Yale JF, Aroda VR, Charbonnel B, Sinclair AJ, Trescoli C, Cahn A, Bigot G, Merino-Trigo A, Brulle-Wohlhueter C, Bolli GB, Ritzel R. Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL versus glargine 100 U/mL: A patient-level meta-analysis examining older and younger adults with type 2 diabetes. Diabetes Metab. 2020 Apr;46(2):110-118. doi: 10.1016/j.diabet.2018.10.002. Epub 2018 Oct 23.
citation: Bonadonna RC, Renard E, Cheng A, Fritsche A, Cali A, Melas-Melt L, Umpierrez GE. Switching to insulin glargine 300 U/mL: Is duration of prior basal insulin therapy important? Diabetes Res Clin Pract. 2018 Aug;142:19-25. doi: 10.1016/j.diabres.2018.03.041. Epub 2018 Apr 9.