Type 2 diabetes mellitus MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients with type 2 diabetes mellitus, as defined by WHO (fasting plasma glucose = 7 mmol/L (126mg/dL) or 2 hours postprandial plasma glucose = 11.1 mmol/L (200 mg/dL)), diagnosed for at least 1 year at the time of screening visit, with or without metformin (stable dose ± 10 % for at least 4 weeks prior to randomization) HbA1c = 7% and = 10% at screening Age eligibility for paediatric population: = 10 years and 85th percentile for age and gender in children, body weight > 50 kg; BMI > 25 kg/m2 and = 37 kg/m2 for adults Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: If female, pregnancy (defined as positive serum pregnancy test), breast-feeding Diabetes other than type 2 diabetes Positive test for insulinoma associated protein (IA2) and glutamic acid decarboxylase (GAD) autoantibodies Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (e.g., alpha glucosidase inhibitor, exenatide, DPP-IV inhibitors, insulin etc.) within 3 months prior to the time of screening Allergic reaction to any GLP-1 agonist in the past (e.g. exenatide, liraglutide) or to metacresol History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls;Secondary Objective: To evaluate in both paediatric and adult populations: - the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single subcutaneous ascending doses - the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast - safety and tolerability.;Primary end point(s): GLU-AUC0:30-4:30h: area under the plasma glucose concentration time profile from time of the standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later subtracting the pre-meal value;Timepoint(s) of evaluation of this end point: D1 at each period up to 4h30 after study drug injection (8 timepoints) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Pharmacokinetics: lixisenatide plasma concentration - Pharmacokinetic parameter (Cmax) - Pharmacokinetic parameter (Tmax) - Pharmacokinetic parameter (AUClast) - Pharmacokinetic parameter (AUC) - Area under the concentration time profile from time of standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later for insulin, C-peptide and glucagon;Timepoint(s) of evaluation of this end point: - Pharmacokinetics: lixisenatide plasma concentration : D1 at each period up to 6h30 after study drug injection (8 timepoints) - Others Pharmacokinetic parameters : D1 at each period - Area under the concentration time profile from time of standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later for insulin, C-peptide and glucagon: D1 at each period up to 4h30 after study drug injection (7 timespoints) | — |
Countries
Germany, Mexico, South Africa, United Kingdom, United States
Outcome results
None listed