CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
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| ClinicalTrials.gov Identifier: NCT00968812 |
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Recruitment Status :
Completed
First Posted : August 31, 2009
Results First Posted : June 4, 2013
Last Update Posted : January 30, 2017
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Brief Summary:
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 | Drug: Glimepiride Drug: Canagliflozin (JNJ-28431754) Drug: Metformin | Phase 3 |
Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of diabetes and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, thereby resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, active comparator-controlled, 3-arm, parallel-group, multicenter study to demonstrate the efficacy, safety, and tolerability of canagliflozin compared with a sulfonylurea (glimepiride) in patients with T2DM, 18 to 80 years of age, inclusive, who are not optimally controlled on metformin monotherapy. The primary study hypothesis is that the study drug will be non-inferior to glimepiride as assessed by the change in hemoglobin A1c (HbA1c) from baseline. The patients will receive capsules taken by mouth of canagliflozin (either 100 or 300 mg), or glimepiride with a starting dosage of 1 mg, which will be increased to a maximum dose of 6 or 8 mg once daily for a total duration of 104 weeks.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1452 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy |
| Study Start Date : | September 2009 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | January 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Glimepiride
Each patient will receive glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
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Drug: Glimepiride
Glimepiride will be given orally (by mouth), as over-encapsulated tablets, starting at a dose of 1mg once daily and increasing to a maximum of 6 mg or 8 mg once daily for 104 weeks.
Other Name: sulfonylurea Drug: Metformin Metformin will be given orally at the protocol-specified dose for 104 weeks. |
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Experimental: Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
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Drug: Canagliflozin (JNJ-28431754)
Canagliflozin (JNJ-28431754) will be given orally as over-encapsulated tablets, at a dose of 100 mg or 300 mg once daily for 104 weeks. Drug: Metformin Metformin will be given orally at the protocol-specified dose for 104 weeks. |
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Experimental: Canagliflozin 300 mg
Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
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Drug: Canagliflozin (JNJ-28431754)
Canagliflozin (JNJ-28431754) will be given orally as over-encapsulated tablets, at a dose of 100 mg or 300 mg once daily for 104 weeks. Drug: Metformin Metformin will be given orally at the protocol-specified dose for 104 weeks. |
Primary Outcome Measures :
- Change in HbA1c From Baseline to Week 52 [ Time Frame: Day 1 (Baseline) and Week 52 ]The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.
Secondary Outcome Measures :
- Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52 [ Time Frame: Day 1 (Baseline) and Week 52 ]The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages.
- Percent Change in Body Weight From Baseline to Week 52 [ Time Frame: Day 1 (Baseline) and Week 52 ]The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change.
- Change in HbA1c From Baseline to Week 104 [ Time Frame: Baseline, Week 104 ]The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have a diagnosis of type 2 diabetes
- Body mass index (BMI) >=22 to <=45 kg/m2, at screening
- Patients must be taking a stable dosage of metformin as monotherapy at screening
- Patients must have a HbA1c between >=7% and <=9.5% at Week 2
- Patients must have a fasting plasma glucose (FPG) <=270 mg/dL (15 mmol/L) at Week -2
Exclusion Criteria:
- Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin
- History of diabetic ketoacidosis or type 1 diabetes mellitus
- History of pancreas or beta-cell transplantation
- History of active proliferative diabetic retinopathy
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
- Taken thiazolidinedione therapy in the past 16 weeks before screening
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968812
Locations
Show 142 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT00968812 |
| Other Study ID Numbers: |
CR016480 28431754DIA3009 ( Other Identifier: Janssen Research & Development, LLC ) 2009-009320-36 ( EudraCT Number ) |
| First Posted: | August 31, 2009 Key Record Dates |
| Results First Posted: | June 4, 2013 |
| Last Update Posted: | January 30, 2017 |
| Last Verified: | December 2016 |
Keywords provided by Janssen Research & Development, LLC:
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Diabetes Metformin Glimepiride |
Hemoglobin A1c Type 2 diabetes mellitus Canagliflozin |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Glimepiride Canagliflozin |
Hypoglycemic Agents Physiological Effects of Drugs Anti-Arrhythmia Agents Immunosuppressive Agents Immunologic Factors Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action |