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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01572649
First received: April 4, 2012
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Lixisenatide (AVE0010)
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 [ Time Frame: D1 at each period up to 4h30 after study drug injection (8 timepoints) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: lixisenatide plasma concentration [ Time Frame: 0 (predose), 30 min, 1h, 1h30, 2h30, 3h30, 4h30 and 6h30 post-dose at D1 of each study period (8 timepoints) ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter (Cmax) [ Time Frame: calculated over the period of timepoints at D1 of each study period ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter (Tmax) [ Time Frame: calculated over the period of timepoints at D1 of each study period ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter (AUC last) [ Time Frame: estimated over the period of timepoints at D1 of each study period ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter (AUC) [ Time Frame: extrapolated based on the period of timepoints at D1 of each study period ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: D1 at each period up to 4h30 after study drug injection (7 timepoints) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
1 single administration (volume matched to the dose lixisenatide: 50 µL or 100µL) once a day subcutaneously
Drug: Placebo

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Experimental: Dose 1
1 single administration of 5 µg lixisenatide (50 µL) once a day subcutaneously
Drug: Lixisenatide (AVE0010)

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Experimental: Dose 2
1 single administration of 10 µg lixisenatide (100 µL) once a day subcutaneously
Drug: Lixisenatide (AVE0010)

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous


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.

  Eligibility

Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572649

Locations
United States, California
Investigational Site Number 840005
Chula Vista, California, United States, 91911
United States, Kansas
Investigational Site Number 840001
Overland Park, Kansas, United States, 66212
United States, Kentucky
Investigational Site Number 840003
Louisville, Kentucky, United States, 40202
Mexico
Investigational Site Number 484001
Puebla, Mexico, 72190
South Africa
Investigational Site Number 710002
Cape Town, South Africa, 7530
United Kingdom
Investigational Site Number 826001
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01572649     History of Changes
Other Study ID Numbers: PKD11475, 2011-004584-67, U1111-1124-3136
Study First Received: April 4, 2012
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 26, 2014