Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes
Completed · Phase 1 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT01572649
- Run by
- Sanofi
- People needed
- 24
- Starts
- 2012-05-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2014-05-23
Who can join
Age: 10 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Investigational Site Number 840005 — Chula Vista, California, United States
- Investigational Site Number 840001 — Overland Park, Kansas, United States
- Investigational Site Number 840003 — Louisville, Kentucky, United States
- Investigational Site Number 484001 — Puebla City, Mexico
- Investigational Site Number 710002 — Cape Town, South Africa
- Investigational Site Number 826001 — Leeds, United Kingdom
Full record on ClinicalTrials.gov
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