A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients with Type 2 Diabetes Mellitus (T2DM)
- Conditions
- Pediatric Patients with Type 2 Diabetes Mellitus Not Adequately Controlled with Metformin and/or Basal InsulinMedDRA version: 19.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2015-005789-42-Outside-EU/EEA
- Lead Sponsor
- SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 28
-Male or female patients aged =10 and <18 years old (at least 4 patients below 16 years old).
-Body mass index (BMI) >85th percentile for age and gender; BMI =50 kg/m^2.
-Male and female patients with documented T2DM insufficiently controlled with metformin =1000 mg/day (or maximum tolerated dose according to the Investigator’s judgment) at a stable dose and regimen for 8 weeks prior to randomization and/or basal insulin at stable dose (±20%) and regimen for 8 weeks prior to randomization.
-Glycated hemoglobin (HbA1c) >6.5% and =11% at screening.
Are the trial subjects under 18? yes
Number of subjects for this age range: 28
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-If female, ongoing pregnancy (defined as positive serum pregnancy test), breast-feeding.
-Sexually active postmenarchal female patient who does not agree to use an adequate and highly
effective method of contraception throughout the study duration and according to local regulation
(ie, hormonal contraception, condom, etc.).
-Diabetes other than T2DM.
-Fasting plasma glucose >250 mg/dL (>13.9 mmol/L) at screening.
-Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin and basal insulin (eg, alpha glucosidase inhibitor, glucagon-like peptide [GLP-1] receptor agonist, dipeptidyl peptidase-IV [DPP-IV] inhibitors, short-acting insulin etc.) within 1 month prior to the screening visit.
-History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate safety of 14-day repeated lixisenatide doses with 3 ascending doses as compared to placebo in pediatric patients with T2DM.;Secondary Objective: -To evaluate plasma concentrations of lixisenatide after repeated doses (3 ascending doses) and pharmacokinetic parameters of repeated lixisenatide doses in pediatric patients with T2DM.<br>-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.;Primary end point(s): - Number of patients with adverse events (AEs)<br>- Number of patients with treatment-emergent adverse events (TEAEs)<br>- Number of patients with anti-lixisenatide antibodies;Timepoint(s) of evaluation of this end point: Up to 10 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1 :<br>- Assessment of PK parameters: lixisenatide plasma concentration<br>- Assessment of pharmacodynamic parameters: plasma glucose AUC-0-4.5 hours, FPG, 1H-PPG excursion and 2H-PPG excursion<br><br>2 :<br>- Assessment of PK parameters: maximum concentration (Cmax)<br>- Assessment of PK parameters: time to reach Cmax (Tmax)<br>- Assessment of PK parameters: area under up to last concentration (AUClast)<br>- Assessment of PK parameters: area under curve (AUC);Timepoint(s) of evaluation of this end point: 1 : Day 14, Day 28 and Day 42<br>2 : Day 42