A Randomized Multicenter Double-Blind Parallel Group Placebo ControlledStudy to Investigate the Efficacy and Safety of Canagliflozin in Children andAdolescents more than equal to 10 to less than 18 years with Type 2 Diabetes Mellitus

Janssen Research Development LLC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Inclusion Criteria
•1 Participants with a diagnosis of type 2 diabetes mellitus T2DM
•2 Random C peptide at screening greater than 0.6 nanogram per milliliter
•more than 0.2 nanomole per liter
•3 HbA1c of greater than or equal to 6.5 percent to less than or equal to
•10.5 percent and either
•A On diet and exercise alone during the 8 weeks prior to screening
•B On diet and exercise and a stable dose of metformin monotherapy more than equal to1000 mg
•per day 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

•Exclusion Criteria
•1 History of diabetic ketoacidosis DKA type 1 diabetes mellitus T1DM pancreas
•or cell transplantation or diabetes secondary to pancreatitis or pancreatectomy or
•maturity onset diabetes of the young MODY
•2 Participants on any antihyperglycemic agents AHAs other than metformin or
•injectable insulin within 8 weeks of the first dose of study drug Day 1
•3. Repeated 2 or more over a 1week period fasting self-monitoring of blood
•glucose SMBG measurements more than 270 milligram/deciliter mg/dL or more than 15 millimole/liter 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

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