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CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00968812
First received: August 28, 2009
Last updated: April 3, 2014
Last verified: April 2014

August 28, 2009
April 3, 2014
September 2009
December 2011   (final data collection date for primary outcome measure)
Change in HbA1c From Baseline to Week 52 [ Time Frame: Day 1 (Baseline) and Week 52 ] [ Designated as safety issue: No ]
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.
The primary efficacy endpoint is the change in Hemoglobin A1c [ Time Frame: From baseline through Week 52 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00968812 on ClinicalTrials.gov Archive Site
  • Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52 [ Time Frame: Day 1 (Baseline) and Week 52 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
The percent change in body weight [ Time Frame: From baseline through Week 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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: 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.
  • 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.
    Interventions:
    • Drug: Glimepiride
    • Drug: Metformin
  • 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.
    Interventions:
    • Drug: Canagliflozin (JNJ-28431754)
    • Drug: Metformin
  • 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.
    Interventions:
    • Drug: Canagliflozin (JNJ-28431754)
    • Drug: Metformin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1452
January 2013
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Bulgaria,   Canada,   Costa Rica,   Denmark,   Finland,   Germany,   India,   Israel,   Korea, Republic of,   Mexico,   Norway,   Philippines,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   Ukraine
 
NCT00968812
CR016480, 28431754DIA3009
Yes
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP