A Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 12.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
- Registration Number
- EUCTR2010-018411-15-GB
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Man or woman > or=55 to < or =80 years of age at screening with T2DM; women must be at least 3 years postmenopausal
•Has an HbA1c > or=7.0% to < or =10.0% at screening (or at Week -2, if HbA1c obtained more than 3 weeks prior to Week -2 visit), and
–Not currently on AHA therapy (off for at least 12 weeks)
or
–On a stable regimen of AHA(s) in monotherapy or on combination therapy, with any approved agent (including metformin, SU, DPP-4 inhibitor, AGI, GLP-1 analogue, or insulin for at least 12 weeks; or pioglitazone for at least 6 months before screening visit) used in accordance with local prescribing information. Note: a stable dose of insulin is defined as no change in the insulin regimen (ie, type[s] of insulin) and < or =15% change in the average total daily dose of insulin (ie, average over 1 week to account for day to day variability, changes < or =15% over the preceding 12 weeks).
•FPG <270 mg/dL (15 mmol/L) at Week -2.
Note: at the investigator’s discretion, based upon review of recent SMBG values, subjects not meeting the Week -2 FPG criteria may return to the investigational site within 7 days for a 1-time repeat FPG and continue in the study if the subject’s repeat FPG meets the criterion.
•Site fasting fingerstick glucose of > or =110 mg/dL (6.1 mmol/L) and <270 mg/dL (15 mmol/L) on Day 1.
Note: at the investigator’s discretion, based upon review of recent SMBG values, subjects not meeting the Day 1 criteria may return to the investigational site within 7 days for a 1-time repeat fingerstick glucose and continue in the study if the subject’s repeat fingerstick glucose meets the criterion.
•Adequate compliance with the run-in period study procedures, including performance of the SMBG measurements (completed at least 3 or more SMBG measurements per week) with appropriate diary entries, and =80% compliance (by pill count) with single-blind placebo capsules
•Body mass index > or =20 to < or =40 kg/m2
•Willing and able to adhere to the prohibitions and restrictions specified in this protocol
•Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
•To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to give consent for this component does not exclude a subject from participation in the clinical study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 < -2.5 (at any site) in a subject not currently on treatment. Note: bone sites referenced by the phrase at any site” include: Composite T-score of evaluable lumbar vertebrae; T-score of the total hip; T-score of femoral neck; T-score of 1/3 radius. Other sites, including individual vertebrae, Ward’s triangle, intertrochanteric region of the hip or (ultra-) distal radius will not be used to determine whether or not a subject meets this exclusion criterion.
•Treatment with a corticosteroid medication within 3 months prior to screening (for more than a total of 14 days in duration) or likely to require treatment with a corticosteroid medication during the subject's participation in the study
•Parathyroid hormone (eg, teriparatide) or denosumab treatment within 12 months before screening
•Severe vitamin D deficiency with serum 25-hydroxy vitamin D level < or =10 ng/mL at screening or within 12 months prior to screening
•Hypercalcemia
•History of rheumatoid or other inflammatory arthritis
•Conditions that interfere with accurate measurement of BMD
•Non-healed fracture, or any fracture with 12 months of screening
•Acquired or inherited bone disorders that may confound assessment of bone density or bone turnover or elevation of alkaline phosphatase >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method