Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus (EDITION IV)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01683266

U1111-1128-5517 (Other Identifier)

EFC12456

2012-001524-35 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 549 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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549 participants in 2 patient groups

HOE901-U300

Experimental group

Description:

HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]).

Treatment:

Drug: HOE901-U300 (Insulin glargine new formulation)

Lantus

Active Comparator group

Description:

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Treatment:

Drug: Lantus (Insulin glargine)