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-DE
• Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single subcutaneous ascending doses<br>- the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast<br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Pharmacokinetics: lixisenatide plasma concentration<br>- Pharmacokinetic parameter (Cmax)<br>- Pharmacokinetic parameter (Tmax)<br>- Pharmacokinetic parameter (AUClast)<br>- Pharmacokinetic parameter (AUC)<br>- 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)<br>- Others Pharmacokinetic parameters : D1 at each period<br>- 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)