Randomized, Double-blind, Placebo-controlled, Dose escalation, Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients with Type 2 Diabetes Mellitus Not Adequately Controlled with Metformin and/or Basal Insulin

SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT0 个研究点目标入组 23 人开始时间: 2016年6月3日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•-Male or female patients aged =10 and <18 years old (at least 4 patients below 16 years old).
•-Body mass index (BMI) >85th percentile for age and gender; BMI =50 kg/m^2.
•-Male and female patients with documented T2DM insufficiently controlled with metformin =1000 mg/day (or maximum tolerated dose according to the Investigator’s judgment) at a stable dose and regimen for 8 weeks prior to randomization and/or basal insulin at stable dose (±20%) and regimen for 8 weeks prior to randomization.
•-Glycated hemoglobin (HbA1c) >6.5% and =11% at screening.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 28
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-If female, ongoing pregnancy (defined as positive serum pregnancy test), breast-feeding.
•-Sexually active postmenarchal female patient who does not agree to use an adequate and highly
•effective method of contraception throughout the study duration and according to local regulation
•(ie, hormonal contraception, condom, etc.).
•-Diabetes other than T2DM.
•-Fasting plasma glucose >250 mg/dL (>13.9 mmol/L) at screening.
•-Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin and basal insulin (eg, alpha glucosidase inhibitor, glucagon-like peptide [GLP-1] receptor agonist, dipeptidyl peptidase-IV [DPP-IV] inhibitors, short-acting insulin etc.) within 1 month prior to the screening visit.
•-History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.

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