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Trial record 1 of 1 for:    pkd11475
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01572649
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE April 4, 2012
First Posted Date  ICMJE April 6, 2012
Last Update Posted Date May 23, 2014
Study Start Date  ICMJE May 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2012)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
  • 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) ]
  • Pharmacokinetic parameter (Cmax) [ Time Frame: calculated over the period of timepoints at D1 of each study period ]
  • Pharmacokinetic parameter (Tmax) [ Time Frame: calculated over the period of timepoints at D1 of each study period ]
  • Pharmacokinetic parameter (AUC last) [ Time Frame: estimated over the period of timepoints at D1 of each study period ]
  • Pharmacokinetic parameter (AUC) [ Time Frame: extrapolated based on the period of timepoints at D1 of each study period ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2012)
  • Pharmacokinetics: lixisenatide plasma concentration [ Time Frame: D1 at each period up to 6h30 after study drug injection (8 timepoints) ]
  • Pharmacokinetic parameter (Cmax) [ Time Frame: D1 at each period ]
  • Pharmacokinetic parameter (Tmax) [ Time Frame: D1 at each period ]
  • Pharmacokinetic parameter (AUC last) [ Time Frame: D1 at each period ]
  • Pharmacokinetic parameter (AUC) [ Time Frame: D1 at each period ]
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Lixisenatide (AVE0010)

    Pharmaceutical form:Solution for injection

    Route of administration: subcutaneous

  • Drug: Placebo

    Pharmaceutical form:Solution for injection

    Route of administration: subcutaneous

Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2012)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   South Africa,   United Kingdom,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT01572649
Other Study ID Numbers  ICMJE PKD11475
2011-004584-67 ( EudraCT Number )
U1111-1124-3136 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date May 2014

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