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Janssen Diabetes study


Title 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
Therapeutic Area Diabetes in Children and Teens (Tufts Children's), Diabetes Mellitus (Tufts Children's), Type II Diabetes (Tufts Children's)
Principal Investigator Sungeeta Agrawal, MD
Min Age 10 Years
Max Age 18 Years
Gender All
Contact Bipin Malla
617-636-1044
bmalla@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03170518

Overview

In children and adolescents (>10 to <18 years) with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control (ie, hemoglobin A1c [HbA1c] of >6.5% to <10.5%), either on diet and exercise only, or on diet and exercise and metformin monotherapy, or on diet and exercise and insulin monotherapy, or on diet and exercise and combination therapy with metformin and insulin.

Study Details

Inclusion Criteria

  • Diagnosis of Type 2 Diabetes Mellitus
  • HbA1c ≥6.5% to ≤10.5%
  • C-peptie >0.6 ng/mL

Exclusion Criteria

  • Type 1 Diabetes
  • History of Diabetic Keto-acidosis
  • On diabetes medication other than Metformin

Study Requirements

Total Study participation duration is for 56 weeks with 12 in-person visits and one phone call; blood draws in 11 of the 12 in person clinic visits; home glucose & HbA1c monitoring (home glucose/HbA1c monitoring device provided by sponsor of the study)