Evaluation of the blood levels of the drug (lixisenatide), the plasma glucose levels and safety in paediatric and adult patients with type 2 diabetes

Conditions: Type 2 diabetes mellitus
MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-004584-67-Outside-EU/EEA

Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 24

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 <18 years with at least 3 patients below 15 years and no more than 3 patients aged between 16 and 18 years; Age eligibility for adults: = 18 and = 65 years
BMI > 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

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)