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

NCT01572649 | Completed Phase 1

• 3 other identifiers: PKD114752011-004584-67U1111-1124-3136
• Study Type: interventional
• Target: 24
• Locations: 4 countries
• Sites: 6

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• 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)

• Pharmacokinetic parameter (Cmax)

  calculated over the period of timepoints at D1 of each study period

• Pharmacokinetic parameter (Tmax)

  calculated over the period of timepoints at D1 of each study period

• Pharmacokinetic parameter (AUC last)

  estimated over the period of timepoints at D1 of each study period

• Pharmacokinetic parameter (AUC)

  extrapolated based on the period of timepoints at D1 of each study period

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Dose 1

EXPERIMENTAL

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

Drug: Lixisenatide (AVE0010)

Dose 2

EXPERIMENTAL

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

Drug: Lixisenatide (AVE0010)

Interventions

Lixisenatide (AVE0010) DRUG

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Dose 1; Dose 2

Placebo DRUG

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Placebo

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (6)

Investigational Site Number 840005

Chula Vista, California, 91911, United States

Location

Investigational Site Number 840001

Overland Park, Kansas, 66212, United States

Location

Investigational Site Number 840003

Louisville, Kentucky, 40202, United States

Location

Investigational Site Number 484001

Puebla City, 72190, Mexico

Location

Investigational Site Number 710002

Cape Town, 7530, South Africa

Location

Investigational Site Number 826001

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lixisenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 6, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

ME (1); US (3); ZA (1); GB (1)