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

NCT ID: NCT01572649

Last Updated: 2014-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-03-31

Brief 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.

Detailed 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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

1 single administration (volume matched to the dose lixisenatide: 50 µL or 100µL) once a day subcutaneously

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Dose 1

1 single administration of 5 µg lixisenatide (50 µL) once a day subcutaneously

Group Type: EXPERIMENTAL

Lixisenatide (AVE0010)

Intervention Type: DRUG

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Dose 2

1 single administration of 10 µg lixisenatide (100 µL) once a day subcutaneously

Group Type: EXPERIMENTAL

Lixisenatide (AVE0010)

Intervention Type: DRUG

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Interventions

Lixisenatide (AVE0010)

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Intervention Type: DRUG

Placebo

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Intervention Type: DRUG

Eligibility 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 (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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840005

Chula Vista, California, United States

Investigational Site Number 840001

Overland Park, Kansas, United States

Investigational Site Number 840003

Louisville, Kentucky, United States

Investigational Site Number 484001

Puebla City, , Mexico

Investigational Site Number 710002

Cape Town, , South Africa

Investigational Site Number 826001

Leeds, , United Kingdom

Countries

United States; Mexico; South Africa; United Kingdom

Other Identifiers

2011-004584-67

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1124-3136

Identifier Type: OTHER

Identifier Source: secondary_id

PKD11475

Identifier Type: -

Identifier Source: org_study_id