Type 2 Diabetes Mellitus MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.) Male or female between the ages 10 to 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 10.5% and meets 1 of the inclusion criteria below: 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 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: 172 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the effect of canagliflozin relative to placebo on HbA1c after 26 weeks of treatment. - To assess the overall safety and tolerability of canagliflozin;Secondary Objective: After 26 weeks of treatment, to assess the effect of canagliflozin relative to placebo in the subset of subjects taking background metformin (with or without insulin) on HbA1c. After 26 weeks of treatment, to assess the effect of canagliflozin relative to placebo on: - FPG - Proportion of subjects with HbA1c <7.5%, <7.0% and <6.5% - Time to rescue therapy and proportion of subjects receiving rescue therapy - Body weight After 52 weeks of treatment, to assess the effect of canagliflozin relative to placebo on: - HbA1c and FPG - Proportion of subjects with HbA1c <7.5%, <7.0% and <6.5% - Time to rescue therapy and proportion of subjects receiving rescue therapy - Body weight Additional Secondary Objectives are listed in the protocol. ;Primary end point(s): The primary efficacy endpoint will be the change in HbA1c from baseline to Week 26.;Timepoint(s) of evaluation of this end point: Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints include: a) change from baseline to Week 26 in FPG, body weight, proportion of subjects with an HbA1c <7.5%, <7.0%, and <6.5%, time to rescue and proportion of subjects receiving rescue therapy. b) change from baseline to Week 52 in FPG, body weight, proportion of subjects with an HbA1c <7.5%, <7.0%, and <6.5%, time to rescue and proportion of subjects receiving rescue therapy. c) change from baseline to Week 52 of BMI, fasting lipid profile, systolic and diastolic blood pressure. d) change in HbA1c from baseline to Week 12.;Timepoint(s) of evaluation of this end point: a) Week 26 b) Week 52 c) Week 26 and Week 52 d) Week 12 | — |
Countries
Brazil, China, Greece, India, Israel, Malaysia, Mexico, Philippines, Poland, Saudi Arabia, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed