Randomized, Double-blind, Placebo-controlled, Dose Escalation, Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin and/or Basal Insulin
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 23
- Locations
- 11
- Primary Endpoint
- Number of patients with adverse events (AEs)
Study Overview
Brief Summary
Primary Objective:
To demonstrate safety of 14-day repeated lixisenatide doses with 3 ascending doses as compared to placebo in pediatric patients with T2DM.
Secondary Objectives:
- To evaluate plasma concentrations of lixisenatide after repeated doses (3 ascending doses) and pharmacokinetic parameters of repeated lixisenatide doses in pediatric patients with T2DM.
- To evaluate the change from baseline in fasting and post-prandial plasma glucose concentrations during a standardized meal test after 3 ascending repeated doses of lixisenatide in comparison to placebo.
Detailed Description
The total study duration will be up to 10 weeks that includes a 6-week treatment period with dose escalation every 2 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 10 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Lixisenatide
Administration of 3 ascending repeated doses of lixisenatide once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.
Intervention: Lixisenatide (AVE0010) (Drug)
Lixisenatide
Administration of 3 ascending repeated doses of lixisenatide once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.
Intervention: Basal Insulin (Drug)
Lixisenatide
Administration of 3 ascending repeated doses of lixisenatide once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.
Intervention: Metformin (Drug)
Placebo
Administration of 3 ascending repeated doses of matching placebo once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.
Intervention: Placebo (Drug)
Placebo
Administration of 3 ascending repeated doses of matching placebo once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.
Intervention: Basal Insulin (Drug)
Placebo
Administration of 3 ascending repeated doses of matching placebo once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.
Intervention: Metformin (Drug)
Outcomes
Primary Outcomes
Number of patients with adverse events (AEs)
Time Frame: Up to 10 weeks
Number of patients with treatment-emergent adverse events (TEAEs)
Time Frame: Up to 10 weeks
Number of patients with anti-lixisenatide antibodies
Time Frame: Up to 10 weeks
Secondary Outcomes
- Assessment of PK parameters: maximum concentration (Cmax)(Day 42)
- Assessment of pharmacokinetic (PK) parameters: lixisenatide plasma concentration(Day 14, Day 28 and Day 42)
- Assessment of PK parameters: time to reach Cmax (Tmax)(Day 42)
- Assessment of PK parameters: area under up to last concentration (AUClast)(Day 42)
- Assessment of PK parameters: area under curve (AUC)(Day 42)
- Assessment of pharmacodynamic parameter: plasma glucose AUC-0-4.5 hours(Day 14, Day 28 and Day 42)