Type 2 Diabetes Mellitus With Inadequate Glycemic Control MedDRA version: 12.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: Canagliflozin
Product Code: JNJ28431754
Pharmaceutical Form: Over encapsulated tablet
INN or Proposed INN: Canagliflozin
Current Sponsor code: JNJ28431754
Concentration unit: mg milligra
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Man or woman > or =18 and 45 years of age with amenorrhea for at least 18 months, or ? >45 years of age with amenorrhea for at least 6 months and 40 IU/mL, or – surgically sterile (have had a hysterectomy, bilateral oophorectomy, or tubal ligation) or otherwise be incapable of pregnancy, or – heterosexually active and practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization, and consistent with local regulations regarding use of birth control methods for subjects participating in clinic
Exclusion criteria
Exclusion criteria: Diabetes-related or Metabolic • History of diabetic ketoacidosis, T1DM, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy • Repeated FPG and/or fasting SMBG glucose measurements =270 mg/dL during the pre-treatment phase, despite reinforcement of diet and exercise counseling. • Have proliferative diabetic retinopathy for which treatment is planned during the course of the study • History of 1 or more severe hypoglycemic episode within 6 months before screening. • History of hereditary glucose-galactose malabsorption or primary renal glucosuria • Ongoing, inadequately controlled thyroid disorder; • Required ongoing insulin therapy within 12 weeks prior to the screening visit • Ongoing eating disorder or significant weight loss or weight gain within 12 weeks, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, subject report Renal/Cardiovascular • Renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant. Note: subjects with a history of treated childhood renal disease, without sequelae, may participate • Myocardial infarction, unstable angina, revascularization procedure), or cerebrovascular accident within 3 months before screening, or revascularization procedure is planned, or subject has a history of New York Heart Association (NYHA) Class III-IV cardiac disease (refer to Attachment 3 of the protocol). • Findings on 12-lead ECG that would require urgent diagnostic evaluation or intervention • Uncontrolled hypertension at Week -2. • History of hepatitis B surface antigen or hepatitis C antibody positive (unless associated with documented persistently stable/normal range aspartate aminotransferase [AST] and ALT levels), or other clinically active liver disease. • History of prior bariatric surgical procedure within 3 years before the screening visit. Note: subjects with bariatric surgery more than 3 years prior to screening must be at a stable weight to be eligible to participate Laboratory • Estimated glomerular filtration rate (eGFR) 2.0 times the ULN or total bilirubin >1.5 times the ULN at screening (for elevations in bilirubin: if, in the opinion of the investigator and agreed upon by the sponsor’s medical officer, the elevation in bilirubin is consistent with Gilbert’s disease, the subject may participate) Other conditions • History of malignancy within 5 years before screening (exceptions: squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy that in the opinion of the investigator, with concurrence with the sponsor’s medical monitor, is considered cured with minimal risk of recurrence) • Clinically important hematologic disorder (eg, symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia) • History of human immunodeficiency virus (HIV) antibody positive • Investigator’s assessment that the subject’s life expectancy is less than 1 year • Any condition that in the opinio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment • To assess the safety and tolerability of canagliflozin ;Secondary Objective: After 26 weeks of treatment, to assess the effect of canagliflozin relative to placebo on: Fasting plasma glucose (FPG); Body weight; Proportion of subjects with HbA1c <7.0% and <6.5% ; Fasting plasma lipids; Fasting measures of beta cell function; Systolic and diastolic blood pressure; Time to rescue therapy and proportion of subjects receiving rescue therapy After 52 weeks of treatment, to assess the effect of canagliflozin relative to baseline on: Glycemic control; Body weight; Proportion of subjects with HbA1c <7.0% and <6.5%; Fasting plasma lipids; Fasting measures of beta cell function; Systolic and diastolic blood pressure; Time to rescue therapy and proportion of subjects receiving rescue therapy ;Primary end point(s): The primary efficacy endpoint will be the change in HbA1c from baseline to Week 26. | — |
Countries
Finland, France, Germany, Greece, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed