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

Sanofi-Aventis Recherche & Développement0 个研究点目标入组 24 人开始时间: 2012年3月29日最近更新: 2012年9月3日

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•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 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
•BMI > 85th percentile for age and gender in children, body weight > 50 kg; BMI > 25 kg/m2 and = 37 kg/m2 for adults
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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)

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