A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (=10 to <18 years) with Type 2 Diabetes Mellitus

Janssen-Cilag International NV0 个研究点开始时间: 2017年11月8日最近更新: 2022年1月24日

研究概览

暂无简介。

•1.) Male or female between the ages = 10 to <18 years at the time of screening.
•2.) Diagnosis of T2DM.
•3.) Random C-peptide at screening >0.6 ng/mL (>0.2 nmol/L)
•4.) Absence of pancreatic autoimmunity (GAD, and islet cell antigen 2 [IA2] antibody negative).
•5.) HbA1c of = 6.5% to = 11.0% and meets 1 of the inclusion criteria below:
•a.) On diet and exercise only for at least 4 weeks prior to screening.
•b.) On diet and exercise and a stable dose of metformin monotherapy = 1,000 mg per day or MTD per day (defined by the investigator) for at least 8 weeks prior to screening,
•c.) On diet and exercise and a stable insulin monotherapy regimen for at least 8 weeks prior to screening
•d.) On diet and exercise and a stable combination therapy with metformin and insulin for at least 8 weeks prior to screening.
•Further inclusion criteria are listed in the protocol.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 146
•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

•Diabetes-Related/Metabolic
•1. History of DKA, T1DM, pancreas or B-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or maturity-onset diabetes of the young (MODY).
•2. On any AHAs other than metformin, or injectable insulin within 8 weeks of the first dose of study drug (ie, Day 1).
•3. Repeated (ie, 2 or more over a 1-week period) fasting SMBG glucose measurements >270 mg/dL (>15 mmol/L) during the pretreatment phase, despite reinforcement of diet and exercise counseling.
•4. Severe hypoglycemia within 6 months prior to Day 1.
•5. History of hereditary glucose-galactose malabsorption or primary renal glucosuria.
•Renal/Cardiovascular
•6. Renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant.
•Gastrointestinal
•7. Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis).
•Further exclusion criteria are listed in the protocol.

发起方