A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study, to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy - CANTATA-MSU Trial
- Conditions
- type 2 diabetes mellitus (T2DM) with inadequate glycemic control on combination therapy with metformin and a sulphonylurea (SU)MedDRA version: 12.1 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus
- Registration Number
- EUCTR2009-016366-88-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 =18 and =80 years of age with T2DM and currently treated with
metformin and an SU
• Meet the following HbA1c eligibility criteria:
HbA1c
Subjects Screening Visit Week -2 Visit
On metformin and an SU at protocol-specified
doses*a for at least 8 weeks prior to screening =7.0% and =10.5% n/a*b
On metformin and an SU, either or both at
doses below protocol-specified*a =7.5% =7.0% and =10.5%
*a= Metformin =2,000 mg/day (or =1,500 mg/day if intolerant of higher dose*b= If measured at screening more than 3 weeks prior to the Week -2 visit, obtain HbA1c at the Week -2 visit to assess inclusion criterion.
• 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 criterion may return to the investigational site
within 7 days for a one-time repeat FPG and continue in the study if the subject’s
repeat FPG meets the criterion
• Site fasting fingerstick glucose of =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 criterion may return to the investigational site within
7 days for a one-time repeat fingerstick glucose and continue in the study if the
subject’s repeat fingerstick glucose meets the criterion
• Women must be:
– postmenopausal, defined as
? >45 years of age with amenorrhea for at least 18 months, or
? >45 years of age with amenorrhea for at least 6 months and <18 months and a
serum follicle stimulating hormone (FSH) level >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 clinical trials, for the duration of their
participation in the study, or
– not heterosexually active
Note: subjects who are not heterosexually active at screening must agree to utilize
a highly effective method of birth control if they become heterosexually active
during their participation in the study.
• Women of childbearing potential must have a negative urine ß-human chorionic
gonadotropin (ß-hCG) pregnancy test at screening and baseline (predose, Day 1)
• Willing and able to adhere to the prohibitions and restriction
• History of diabetic ketoacidosis, T1DM, pancreas or beta-cell transplantation, or
diabetes secondary to pancreatitis or pancreatectomy
• Repeated (ie, 2 or more over a 1-week period) FPG and/or fasting SMBG
measurements =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.
Note: a severe hypoglycemic episode is defined as an event that requires the help of
another person (refer to Attachment 4, Hypoglycemia: Definitions, Symptoms, and
Treatment, for a definition of severe hypoglycemia)
• History of hereditary glucose-galactose malabsorption or primary renal glucosuria
• Ongoing, inadequately controlled thyroid disorder (eg, subject has a known thyroid
stimulating hormone [TSH] value that is either <0.2 or >10 mIU/L)
Note: subjects on thyroid hormone replacement therapy must be on stable doses for at least 6 weeks prior to Day 1
• On either a PPAR? agonist (eg, a thiazolidinedione [pioglitazone or rosiglitazone]) ongoing insulin therapy, another SGLT2 inhibitor, or any other AHA (including agents such as colesevelam and bromocriptine that have indications in some regions for treatment of T2DM) except as specified in the study inclusion criteria within 12 weeks before the screening visit
Note: subjects who have been treated with only a single dose of insulin may
participate.
• 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
• 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 (eg, stent or
bypass graft surgery), 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
• Findings on 12-lead ECG that would require urgent diagnostic evaluation or
intervention (eg, new clinically important arrhythmia or conduction disturbance)
• Uncontrolled hypertension (ie, using an average of 3 seated blood pressure readings with a diastolic blood pressure =100 mmHg or systolic blood pressure =160 mmHg) at Week -2
Note: subjects may have their blood pressure lowering medication regimen adjusted
and be re-evaluated to assess this criterion
• History of hepatitis B surface antigen or hepatitis C antibody positive (unless
associated with documented persistently stable/normal range aspartate
aminotrans
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