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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

April 4, 2012
May 22, 2014
May 2012
March 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01572649 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Pharmacokinetics: lixisenatide plasma concentration [ Time Frame: D1 at each period up to 6h30 after study drug injection (8 timepoints) ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter (Cmax) [ Time Frame: D1 at each period ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter (Tmax) [ Time Frame: D1 at each period ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter (AUC last) [ Time Frame: D1 at each period ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter (AUC) [ Time Frame: D1 at each 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 ]
Not Provided
Not Provided
 
Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Lixisenatide (AVE0010)

    Pharmaceutical form:Solution for injection

    Route of administration: subcutaneous

  • Drug: Placebo

    Pharmaceutical form:Solution for injection

    Route of administration: subcutaneous

  • Placebo Comparator: Placebo
    1 single administration (volume matched to the dose lixisenatide: 50 µL or 100µL) once a day subcutaneously
    Intervention: Drug: Placebo
  • Experimental: Dose 1
    1 single administration of 5 µg lixisenatide (50 µL) once a day subcutaneously
    Intervention: Drug: Lixisenatide (AVE0010)
  • Experimental: Dose 2
    1 single administration of 10 µg lixisenatide (100 µL) once a day subcutaneously
    Intervention: Drug: Lixisenatide (AVE0010)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2014
March 2014   (final data collection date for primary outcome measure)

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.

Both
10 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico,   South Africa,   United Kingdom
 
NCT01572649
PKD11475, 2011-004584-67, U1111-1124-3136
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP