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 is currently recruiting participants.
Verified May 2013 by Sanofi
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01572649
First received: April 4, 2012
Last updated: May 15, 2013
Last verified: May 2013
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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 ]
| Estimated Enrollment: | 24 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572649
Contacts
| Contact: For site information, send an email with site number to | Contact-Us@sanofi.com |
Locations
| United States, California | |
| Investigational Site Number 840005 | Recruiting |
| Chula Vista, California, United States, 91911 | |
| United States, Kansas | |
| Investigational Site Number 840001 | Completed |
| Overland Park, Kansas, United States, 66212 | |
| United States, Kentucky | |
| Investigational Site Number 840003 | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Investigational Site Number 840009 | Recruiting |
| Baton Rouge, Louisiana, United States, 70808 | |
| Germany | |
| Investigational Site Number 276001 | Recruiting |
| Hannover, Germany, 30173 | |
| Mexico | |
| Investigational Site Number 484001 | Recruiting |
| Puebla, Mexico, 72190 | |
| South Africa | |
| Investigational Site Number 710002 | Recruiting |
| Cape Town, South Africa, 7530 | |
| Investigational Site Number 710001 | Recruiting |
| Observatory, South Africa, 7925 | |
| Investigational Site Number 710003 | Recruiting |
| Pretoria, South Africa, 0184 | |
| United Kingdom | |
| Investigational Site Number 826001 | Recruiting |
| 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 15, 2013 |
| 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 May 23, 2013