Clinical trial NCT01683266: Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
Official title: A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-09-11
Enrollment: 549
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 a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus

Secondary Objective:

* To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of:
* Change of HbA1c from baseline to endpoint (scheduled Month 6)
* Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)
* Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia)
* Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)
* Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period

Detailed description: The maximum study duration was up to approximately 54 weeks per participants:

* Up to 2-week screening period
* 6-month open-label comparative efficacy and safety treatment period
* 6-month open-label comparative safety extension period
* 48-hour post-treatment safety follow-up period

Eligibility criteria: Inclusion criteria:

* Adult participants with type 1 diabetes mellitus

Exclusion criteria:

* HbA1c less than (\<) 7.0% (53 mmol/mol) or greater than (\>) 10% (86 mmol/mol) at screening
* Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit
* Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit
* Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
* Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months
* Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;
* Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit
* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (example laser, surgical treatment or injectable drugs) during the study period

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 HbA1c <7% at Month 6 Endpoint
timeFrame: Month 6
measure: Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint
timeFrame: Month 6
measure: Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6
timeFrame: Month 6
measure: Percentage of Participants With FPG <7.2 mmol/L (130 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 Average Total Insulin Dose From Baseline to Month 6 Endpoint
timeFrame: Baseline, Month 6
measure: Change in Total 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 to Month 12
timeFrame: Up to Month 12
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Investigational Site Number 840156
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site Number 840177
state: Arkansas
city: Bell Gardens
country: United States
facility: Investigational Site Number 840430
state: California
city: Escondido
country: United States
facility: Investigational Site Number 840131
state: California
city: Fresno
country: United States
facility: Investigational Site Number 840140
state: California
city: Greenbrae
country: United States
facility: Investigational Site Number 840107
state: California
city: Huntington Beach
country: United States
facility: Investigational Site Number 840149
state: California
city: La Jolla
country: United States
facility: Investigational Site Number 840120
state: California
city: La Mesa
country: United States
facility: Investigational Site Number 840123
state: California
city: La Mesa
country: United States
facility: Investigational Site Number 840159
state: California
city: Long Beach
country: United States
facility: Investigational Site Number 840114
state: California
city: Mission Hills
country: United States
facility: Investigational Site Number 840189
state: California
city: Temecula
country: United States
facility: Investigational Site Number 840105
state: California
city: Tustin
country: United States
facility: Investigational Site Number 840155
state: California
city: Walnut Creek
country: United States
facility: Investigational Site Number 840115
state: California
city: Denver
country: United States
facility: Investigational Site Number 840160
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840188
state: Colorado
city: New Haven
country: United States
facility: Investigational Site Number 840196
state: Connecticut
city: Bradenton
country: United States
facility: Investigational Site Number 840113
state: Florida
city: Hialeah
country: United States
facility: Investigational Site Number 840102
state: Florida
city: Hollywood
country: United States
facility: Investigational Site Number 840134
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840185
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840116
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840126
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840179
state: Florida
city: New Port Richey
country: United States
facility: Investigational Site Number 840117
state: Florida
city: Orlando
country: United States
facility: Investigational Site Number 840174
state: Florida
city: Oviedo
country: United States
facility: Investigational Site Number 840110
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 840178
state: Florida
city: Tampa
country: United States
facility: Investigational Site Number 840181
state: Florida
city: West Palm Beach
country: United States
facility: Investigational Site Number 840420
state: Florida
city: Atlanta
country: United States
facility: Investigational Site Number 840195
state: Georgia
city: Honolulu
country: United States
facility: Investigational Site Number 840124
state: Hawaii
city: Idaho Falls
country: United States
facility: Investigational Site Number 840167
state: Idaho
city: Nampa
country: United States
facility: Investigational Site Number 840163
state: Idaho
city: Springfield
country: United States
facility: Investigational Site Number 840162
state: Illinois
city: Avon
country: United States
facility: Investigational Site Number 840172
state: Indiana
city: Indianapolis
country: United States
facility: Investigational Site Number 840197
state: Indiana
city: Des Moines
country: United States
facility: Investigational Site Number 840108
state: Iowa
city: Iowa City
country: United States
facility: Investigational Site Number 840407
state: Iowa
city: Topeka
country: United States
facility: Investigational Site Number 840170
state: Kansas
city: Lexington
country: United States
facility: Investigational Site Number 840421
state: Kentucky
city: Metairie
country: United States
facility: Investigational Site Number 840426
state: Louisiana
city: Baltimore
country: United States
facility: Investigational Site Number 840104
state: Maryland
city: Rockville
country: United States
facility: Investigational Site Number 840180
state: Maryland
city: Haverhill
country: United States
facility: Investigational Site Number 840137
state: Massachusetts
city: Detroit
country: United States
facility: Investigational Site Number 840408
state: Michigan
city: Madison Heights
country: United States
facility: Investigational Site Number 840153
state: Michigan
city: St Louis Park
country: United States
facility: Investigational Site Number 840171
state: Minnesota
city: St Louis
country: United States
facility: Investigational Site Number 840184
state: Missouri
city: Omaha
country: United States
facility: Investigational Site Number 840106
state: Nebraska
city: Omaha
country: United States
facility: Investigational Site Number 840145
state: Nebraska
city: Las Vegas
country: United States
facility: Investigational Site Number 840139
state: Nevada
city: Albuquerque
country: United States
facility: Investigational Site Number 840151
state: New Mexico
city: New Hyde Park
country: United States
facility: Investigational Site Number 840191
state: New York
city: Syracuse
country: United States
facility: Investigational Site Number 840173
state: New York
city: Asheville
country: United States
facility: Investigational Site Number 840133
state: North Carolina
city: Chapel Hill
country: United States
facility: Investigational Site Number 840175
state: North Carolina
city: Morganton
country: United States
facility: Investigational Site Number 840161
state: North Carolina
city: Mentor
country: United States
facility: Investigational Site Number 840169
state: Ohio
city: Norman
country: United States
facility: Investigational Site Number 840119
state: Oklahoma
city: Bend
country: United States
facility: Investigational Site Number 840112
state: Oregon
city: Greer
country: United States
facility: Investigational Site Number 840136
state: South Carolina
city: Dakota Dunes
country: United States
facility: Investigational Site Number 840122
state: South Dakota
city: Chattanooga
country: United States
facility: Investigational Site Number 840144
state: Tennessee
city: Nashville
country: United States
facility: Investigational Site Number 840187
state: Tennessee
city: Austin
country: United States
facility: Investigational Site Number 840109
state: Texas
city: Austin
country: United States
facility: Investigational Site Number 840157
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840150
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840412
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840130
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840141
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840166
state: Texas
city: Murray
country: United States
facility: Investigational Site Number 840101
state: Utah
city: Burke
country: United States
facility: Investigational Site Number 840125
state: Virginia
city: Chesapeake
country: United States
facility: Investigational Site Number 840427
state: Virginia
city: Manassas
country: United States
facility: Investigational Site Number 840103
state: Virginia
city: Renton
country: United States
facility: Investigational Site Number 840132
state: Washington
city: Seattle
country: United States
facility: Investigational Site Number 840403
state: Washington
city: Spokane
country: United States
facility: Investigational Site Number 840402
state: Washington
city: Tacoma
country: United States
facility: Investigational Site Number 840127
state: Washington
city: Milwaukee
country: United States
facility: Investigational Site Number 840411
state: Wisconsin
city: Coquitlam
country: Canada
facility: Investigational Site Number 124110
city: Laval
country: Canada
facility: Investigational Site Number 124104
city: Mirabel
country: Canada
facility: Investigational Site Number 124108
city: Montreal
country: Canada
facility: Investigational Site Number 124109
city: Thornhill
country: Canada
facility: Investigational Site Number 124105
city: Toronto
country: Canada
facility: Investigational Site Number 124101
city: Brno
country: Czech Republic
facility: Investigational Site Number 203102
city: Praha 10
country: Czech Republic
facility: Investigational Site Number 203104
city: Praha 8
country: Czech Republic
facility: Investigational Site Number 203103
city: Esbjerg
country: Denmark
facility: Investigational Site Number 208103
city: Gentofte
country: Denmark
facility: Investigational Site Number 208105
city: København Nv
country: Denmark
facility: Investigational Site Number 208104
city: Køge
country: Denmark
facility: Investigational Site Number 208107
city: Ålborg
country: Denmark
facility: Investigational Site Number 208102
city: Pärnu
country: Estonia
facility: Investigational Site Number 233104
city: Tallinn
country: Estonia
facility: Investigational Site Number 233105
city: Tartu
country: Estonia
facility: Investigational Site Number 233106
city: Tartu
country: Estonia
facility: Investigational Site Number 233101
city: Viljandimaa
country: Estonia
facility: Investigational Site Number 233103
city: Kokkola
country: Finland
facility: Investigational Site Number 246102
city: Kuopio
country: Finland
facility: Investigational Site Number 246101
city: Loimaa
country: Finland
facility: Investigational Site Number 246106
city: Oulu
country: Finland
facility: Investigational Site Number 246105
city: Tampere
country: Finland
facility: Investigational Site Number 246103
city: Budapest
country: Hungary
facility: Investigational Site Number 348103
city: Budapest
country: Hungary
facility: Investigational Site Number 348108
city: Budapest
country: Hungary
facility: Investigational Site Number 348107
city: Debrecen
country: Hungary
facility: Investigational Site Number 348106
city: Gyula
country: Hungary
facility: Investigational Site Number 348102
city: Urhida
country: Hungary
facility: Investigational Site Number 348101
city: Aisai-Shi
country: Japan
facility: Investigational Site Number 392110
city: Ise-Shi
country: Japan
facility: Investigational Site Number 392105
city: Karatsu-Shi
country: Japan
facility: Investigational Site Number 392104
city: Kitakyushu-Shi
country: Japan
facility: Investigational Site Number 392111
city: Matsumoto-Shi
country: Japan
facility: Investigational Site Number 392112
city: Matumoto
country: Japan
facility: Investigational Site Number 392108
city: Midori-Shi
country: Japan
facility: Investigational Site Number 392103
city: Mito-Shi
country: Japan
facility: Investigational Site Number 392107
city: Sakai-Shi
country: Japan
facility: Investigational Site Number 392101
city: Tomishiro
country: Japan
facility: Investigational Site Number 392102
city: Yamagata-Shi
country: Japan
facility: Investigational Site Number 392106
city: Limbazi
country: Latvia
facility: Investigational Site Number 428106
city: Riga
country: Latvia
facility: Investigational Site Number 428103
city: Riga
country: Latvia
facility: Investigational Site Number 428105
city: Sigulda
country: Latvia
facility: Investigational Site Number 428102
city: Ventspils
country: Latvia
facility: Investigational Site Number 428101
city: Almere
country: Netherlands
facility: Investigational Site Number 528101
city: Beek
country: Netherlands
facility: Investigational Site Number 528103
city: Nijmegen
country: Netherlands
facility: Investigational Site Number 528105
city: Venlo
country: Netherlands
facility: Investigational Site Number 528104
city: Zwijndrecht
country: Netherlands
facility: Investigational Site Number 528102
city: Ponce
country: Puerto Rico
facility: Investigational Site Number 840602
city: Bacau
country: Romania
facility: Investigational Site Number 642107
city: Brasov
country: Romania
facility: Investigational Site Number 642103
city: Oradea
country: Romania
facility: Investigational Site Number 642109
city: Resita
country: Romania
facility: Investigational Site Number 642106
city: Sibiu
country: Romania
facility: Investigational Site Number 642104
city: Targu Mures
country: Romania
facility: Investigational Site Number 642101
city: Targu Mures
country: Romania
facility: Investigational Site Number 642102
city: Timisoara
country: Romania
facility: Investigational Site Number 642105
city: Timisoara
country: Romania
facility: Investigational Site Number 642108
city: Goteborg
country: Sweden
facility: Investigational Site Number 752103
city: Kristianstad
country: Sweden
facility: Investigational Site Number 752105
city: Stockholm
country: Sweden
facility: Investigational Site Number 752101
city: Vällingby
country: Sweden
facility: Investigational Site Number 752104
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Home PD, Bergenstal RM, Bolli GB, Ziemen M, Rojeski M, Espinasse M, Riddle MC. Glycaemic control and hypoglycaemia during 12 months of randomized treatment with insulin glargine 300 U/mL versus glargine 100 U/mL in people with type 1 diabetes (EDITION 4). Diabetes Obes Metab. 2018 Jan;20(1):121-128. doi: 10.1111/dom.13048. Epub 2017 Aug 8.