Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Lixisenatide (AVE0010); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01632163

U1111-1124-1213 (Other Identifier)

EFC12382

Details and patient eligibility

About

Primary Objective:

• To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients.

Secondary Objectives:

• To assess the effects of lixisenatide over 24 weeks on :

  • percentage of patients reaching HbA1c<7% or ≤6.5%,
  • 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test,
  • fasting plasma glucose (FPG),
  • change in 7-point self-monitored plasma glucose (SMPG) profile),
  • body weight,
  • change in daily basal insulin dose.

• To assess lixisenatide safety and tolerability.

• To assess anti-lixisenatide antibody development.

Full description

Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up)

Enrollment: 447 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year at the time of the screening visit insufficiently controlled with basal insulin± metformin.

Exclusion criteria:

At screening:

• Age < legal age of adulthood.
• HbA1c<7% or >10.5%.
• Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit.
• If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit.
• History of hypoglycemia unawareness.
• Body Mass Index (BMI) ≤20 kg/m².
• Use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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447 participants in 2 patient groups, including a placebo group

Lixisenatide

Experimental group

Description:

24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)

Treatment:

Drug: Lixisenatide (AVE0010)

Placebo

Placebo Comparator group

Description:

24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)

Treatment:

Drug: Placebo