Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

Condition(s) targeted: Type 1 Diabetes Mellitus

Intervention: HOE901-U300 (Insulin glargine new formulation) (Drug); Lantus (Insulin glargine) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

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

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change In HbA1c From Baseline to Month 6 Endpoint

Secondary outcome:

Percentage of Participants With HbA1c <7% at Month 6 Endpoint

Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint

Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint

Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint

Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint

Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6

Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint

Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint

Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint

Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint

Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Investigational Site Number 124110, Coquitlam V3K 3P4, Canada

Investigational Site Number 124104, Laval H7T 2P5, Canada

Investigational Site Number 124108, Mirabel J7J 2K8, Canada

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Investigational Site Number 233104, Pärnu 80018, Estonia

Investigational Site Number 233105, Tallinn 13419, Estonia

Investigational Site Number 233101, Tartu 50410, Estonia

Investigational Site Number 233106, Tartu 50406, Estonia

Investigational Site Number 233103, Viljandimaa 71024, Estonia

Investigational Site Number 246102, Kokkola 67100, Finland

Investigational Site Number 246101, Kuopio 70210, Finland

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Investigational Site Number 246105, Oulu 90100, Finland

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Investigational Site Number 392108, Matumoto, Japan

Investigational Site Number 392103, Midori-Shi, Japan

Investigational Site Number 392107, Mito-Shi, Japan

Investigational Site Number 392101, Sakai-Shi, Japan

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Starting date: September 2012
Last updated: May 28, 2015