The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
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Purpose
The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Canagliflozin 100 mg Drug: Canagliflozin 300 mg Drug: Placebo Drug: Sitagliptin 100 mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise |
- To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) in the main study. [ Time Frame: After 26 weeks of treatment with study drug. ] [ Designated as safety issue: No ]
- To assess the effect of study drug on HbA1c [ Time Frame: After 52 weeks of treatment in the main study ] [ Designated as safety issue: No ]
- To assess the effects of study drug on fasting plasma glucose (FPG) and body weight [ Time Frame: After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy) ] [ Designated as safety issue: No ]
- To assess the effect of study drug on postprandial plasma glucose concentrations. [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
- To assess the effect of study drug on proportion of patients achieving an HbA1c <7%. [ Time Frame: After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy) ] [ Designated as safety issue: No ]
- To assess effects of study drug on systolic and diastolic blood pressure and fasting plasma lipids. [ Time Frame: After 26 and 52 weeks of treatment (after 26 weeks in the high glycemic cohort substudy) ] [ Designated as safety issue: No ]
| Enrollment: | 678 |
| Study Start Date: | March 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Canagliflozin 100 mg |
Drug: Canagliflozin 100 mg
One 100-mg capsule once daily for 52 weeks (Main Study) or one 100-mg capsule once daily for 26 weeks (high glycemic cohort substudy)
|
| Experimental: Canagliflozin 300 mg |
Drug: Canagliflozin 300 mg
One 300-mg capsule once daily for 52 weeks (Main Study) or one 300-mg capsule once daily for 26 weeks (high glycemic cohort substudy)
|
|
Experimental: Placebo Cross-over to Sitagliptin
Patients will receive double-blind treatment with placebo once daily for 26 weeks then switched to treatment with sitagliptin 100 mg once daily beginning at Week 26 for 26 weeks.
|
Drug: Placebo
1 placebo capsule once daily for 26 weeks, then crossover to sitagliptin (Main Study)
Drug: Sitagliptin 100 mg
One 100 mg capsule sitagliptin once daily beginning at Week 26 for 26 weeks (Main Study)
|
Detailed Description:
Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), double blind (neither the patient or the study doctor will know the name of the assigned treatment), parallel-group, 3 arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes. Approximately 450 patients with inadequate glycemic control with diet and exercise will receive once-daily treatment with canagliflozin 100 mg or 300 mg once daily for 52 weeks or 26 weeks of double-blind treatment with placebo followed by 26 weeks of sitagliptin 100 mg (sitagliptin is an antihyperglycemic agent that will allow patients randomized to the placebo group to improve glycemic control and remain in the study). Patients will participate in the study for approximately 60 to 68 weeks (referred to as the Main Study). The study will also include a High Glycemic Cohort Substudy in 50 to 100 patients with T2DM who have poorer glycemic control with diet and exercise. Patients in the substudy will be assigned to receive double-blind canagliflozin 100 mg or 300 mg for 26 weeks and the total duration of patient participatation in the substudy will be approximately 34 to 42 weeks. During treatment, if a patient's fasting blood sugar remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with metformin (rescue therapy) consistent with local prescribing information. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. Patients will take single blind placebo for 1 or 2 weeks (wks) before randomization to the Main Study or the High Glycemic Cohort Substudy.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients must have a diagnosis of T2DM
- Patients in the main study must have a Hemoglobin A1c (HbA1c) between >=7% and <=10% and a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)
- Patients in the High Glycemic Cohort Substudy must have an HbA1c between >10% and <=12% and a FPG <=350 mg/dL (19.44 mmol/L)
Exclusion Criteria:
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening
Contacts and Locations
Show 79 Study Locations| Study Director: | Janssen Research & Development, LLC C. Clinical Trial | Janssen Research & Development, LLC |
More Information
No publications provided
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT01081834 History of Changes |
| Other Study ID Numbers: | CR017011, 28431754DIA3005 |
| Study First Received: | March 4, 2010 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Food and Drug Administration Philippines: Bureau of Food and Drugs |
Keywords provided by Janssen Research & Development, LLC:
|
Diabetes Mellitus, Type 2 Canagliflozin Placebo Hemoglobin A1c Type 2 diabetes mellitus |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013