A Study 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
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2018/05/013845
- Lead Sponsor
- Janssen Research Development LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Glycated Hemoglobin HbA1c from Baseline at Week 26Timepoint: Change in Glycated Hemoglobin HbA1c from Baseline at Week 26
- Secondary Outcome Measures
Name Time Method Change in Body Weight From Baseline at Week 26 and Week 52Timepoint: Baseline Day 1 Week 26 and Week 52;Change in Fasting Plasma Glucose FPG from Baseline at Week 26 and Week 52Timepoint: Baseline Day 1, Week 26, and Week 52;Percentage of Participants who will Receive Rescue TherapyTimepoint: Week 26 and Week 52;Percentage of Participants With HbA1c less than 6.5 percent at Week 26 and Week 52Timepoint: Week 26 and Week 52;Percentage of Participants With HbA1c less than 7.0 percent at Week 26 and Week 52Timepoint: Week 26 and Week 52;Percentage of Participants With HbA1c less <br/ ><br>than 7.5 percent at Week 26 and Week 52Timepoint: Week 26 and Week 52;Time to Rescue TherapyTimepoint: Baseline Day 1 up to Week 26 and Week 52