Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Paediatric (10 - 17 Years Old) and Adult Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572649
• Other study ID #: PKD11475
• Secondary ID: 2011-004584-67U1
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2012
• Last updated: May 22, 2014
• Start date: May 2012
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary 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 Objectives:

• 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.

Description:

The duration of the study for each patient is planned between 4 and 7 weeks including a screening period (25 to 30 days), 3 treatment periods 1-7 days apart, each period lasting only one day (Day 1) and an end-of-study visit between 1 to 7 days after the last dose administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 65 Years

Eligibility

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 (adults) and at least 3 months for paediatric population 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

• For paediatric population:body weight >50kg, BMI >85th percentile for age and gender and BMI = 50 kg/m²

• For adults: BMI > 25 kg/m2 and = 37 kg/m2

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)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Lixisenatide (AVE0010)
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
• Placebo
Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
Mexico	Investigational Site Number 484001	Puebla
South Africa	Investigational Site Number 710002	Cape Town
United Kingdom	Investigational Site Number 826001	Leeds
United States	Investigational Site Number 840005	Chula Vista	California
United States	Investigational Site Number 840003	Louisville	Kentucky
United States	Investigational Site Number 840001	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Mexico,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GLU-AUC 0:30-4:30h: 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		D1 at each period up to 4h30 after study drug injection (8 timepoints)	No
Secondary	Pharmacokinetics: lixisenatide plasma concentration		0 (predose), 30 min, 1h, 1h30, 2h30, 3h30, 4h30 and 6h30 post-dose at D1 of each study period (8 timepoints)	No
Secondary	Pharmacokinetic parameter (Cmax)		calculated over the period of timepoints at D1 of each study period	No
Secondary	Pharmacokinetic parameter (Tmax)		calculated over the period of timepoints at D1 of each study period	No
Secondary	Pharmacokinetic parameter (AUC last)		estimated over the period of timepoints at D1 of each study period	No
Secondary	Pharmacokinetic parameter (AUC)		extrapolated based on the period of timepoints at D1 of each study period	No
Secondary	Area under the concentration time profile from time of standardized breakfast start (30 min after IMP injection) until 4 hours later for insulin, C-peptide and glucagon		D1 at each period up to 4h30 after study drug injection (7 timepoints)	No