Type 2 Diabetes Mellitus
Conditions
Brief summary
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.
Detailed 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)
Interventions
DRUGLixisenatide (AVE0010)
Pharmaceutical form:solution Route of administration: subcutaneous injection
DRUGPlacebo
Pharmaceutical form:solution Route of administration: subcutaneous injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | from baseline to week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change in 2-hour postprandial plasma glucose and plasma glucose excursion | from baseline to week 24 |
| Change in fasting plasma glucose | from baseline to week 24 |
| Change in 7-point self monitoring plasma glucose profile (average and each point) | from baseline to week 24 |
| Percentage of patients with HbA1c <7%, =<6.5% | at week 24 |
| Change in daily basal insulin dose | from baseline to week 24 |
| Number of patients with adverse events | 24 weeks |
| Anti-lixisenatide antibody assessment | from baseline to week 24 |
| Change in body weight | from baseline to week 24 |
Countries
China, India, Russia, South Korea
Outcome results
None listed