Type 2 Diabetes Mellitus MedDRA version: 12.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: Canagliflozin - capsule - 100 mg (eq. 100 mg base)
Product Code: JNJ-28431754
Pharmaceutical Form: Over encapsulated tablet
INN or Proposed INN: Canagliflozin
CAS Number: 842133-18-0
Cur
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Man or woman > or=55 to or=7.0% to or =110 mg/dL (6.1 mmol/L) and or =20 to =65 years) yes F.1.3.1 Number of subjects for this age range
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 measurements > or =270 mg/dL (15 mmol/L) during the pretreatment 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 • Ongoing eating disorder or significant weight loss or weight gain within 12 weeks before the screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, subject report Muscular/Skeletal • Use of a bisphosphonate within 12 months prior to screening or expected to receive treatment with bisphosphonate during the study period • If on medication treatment for osteoporosis (eg, estrogen replacement, selective estrogen receptor modulator [SERM] therapy, or calcitonin), not on a stable regimen (for at least 6 months prior to screening) • T score 1.5xULN Renal/Cardiovascular • Renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant. • 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, New York Heart Association Classification of Cardiac Disease, for a description of the classes). • Findings on 12-lead ECG that would require urgent diagnostic evaluation or intervention • Uncontrolled hypertension (ie, using an average of 3 seated blood pressure readings with a diastolic blood pressure > or =100 mmHg or systolic blood pressure > or =160 mmHg) at Week -2. Gastrointestinal • 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. Laboratory • Estimated glomerular filtration rate (eGFR) or =1.4 mg/dL (124 micromol/L) for men and > or =1.3 mg/dL (115 micromol/L)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the effect of the addition of treatment with canagliflozin relative to the addition of 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: Bone mineral density at the lumbar spine, hip, and distal forearm as measured by dual energy X-ray absorptiometry (DXA); Markers of bone turnover; Proportion of subjects achieving HbA1c <7.0% and <6.5%; Fasting plasma glucose; Body weight; Fasting plasma lipids ; Systolic and diastolic blood pressure; Time to rescue therapy and proportion of subjects receiving rescue therapy; Body composition as measured by DXA in a subset of subjects. After 52 weeks of treatment, to assess the effect of canagliflozin relative to placebo on: Bone mineral density at the lumbar spine, hip, and distal forearm as measured by DXA; Glycemic control; Proportion of subjects achieving HbA1c <7.0% and <6.5%; Body weight; Fasting plasma lipids; Systolic and diastolic blood pressure. After 104 weeks of treatment, please refer to section 2.1.2 of the protocol for complete description. ;Primary end point(s): The primary efficacy endpoint will be the change in HbA1c from baseline to Week 26. | — |
Countries
France, Greece, Poland, Spain, Sweden, United Kingdom
Outcome results
None listed