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Trial record 1 of 1 for:    NCT01081834
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The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

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ClinicalTrials.gov Identifier: NCT01081834
Recruitment Status : Completed
First Posted : March 5, 2010
Results First Posted : June 3, 2013
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE March 4, 2010
First Posted Date  ICMJE March 5, 2010
Results First Submitted Date  ICMJE April 15, 2013
Results First Posted Date  ICMJE June 3, 2013
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE March 2010
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2013)
  • Change in HbA1c From Baseline to Week 26 (Main Study) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
  • Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2010)
To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c). [ Time Frame: After 26 weeks of treatment with study drug. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2013)
  • Percentage of Patients With HbA1c <7% at Week 26 (Main Study) [ Time Frame: Week 26 ]
    The table below shows the percentage of patients with HbA1c <7% at Week 26. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (Main Study) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
  • Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
  • Percent Change in Body Weight From Baseline to Week 26 (Main Study) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
  • Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
  • Percent Change in Triglycerides From Baseline to Week 26 (Main Study) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
  • Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
  • Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy) [ Time Frame: Week 26 ]
    The table below shows the percentage of patients with HbA1c <7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
  • Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
  • Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
  • Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
  • Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
  • Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy) [ Time Frame: Day 1 (Baseline) and Week 26 ]
    The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2010)
  • To assess the effects of study drug on fasting plasma glucose (FPG) and body weight [ Time Frame: After 26 and 52 weeks of treatment ]
  • To assess the effect of study drug on postprandial plasma glucose concentrations. [ Time Frame: After 26 weeks of treatment ]
  • To assess the effect of study drug on proportion of patients achieving an HbA1c <7%. [ Time Frame: After 26 and 52 weeks of treatment ]
  • 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 ]
  • To assess the effect of study drug on HbA1c [ Time Frame: After 52 weeks of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
Official Title  ICMJE 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
Brief Summary 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.
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 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 Substudy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Canagliflozin
    One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks (Main Study) or 26 weeks (High Glycemic Substudy)
  • Drug: Placebo
    One matching placebo capsule orally once daily for 26 weeks (Main Study)
  • Drug: Sitagliptin
    One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 (Main Study)
Study Arms  ICMJE
  • Experimental: Canagliflozin 100 mg
    Each patient will receive 100 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).
    Intervention: Drug: Canagliflozin
  • Experimental: Canagliflozin 300 mg
    Each patient will receive 300 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).
    Intervention: Drug: Canagliflozin
  • Experimental: Placebo/Sitagliptin
    In the Main Study, each patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52.
    Interventions:
    • Drug: Placebo
    • Drug: Sitagliptin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2012)
678
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2010)
450
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Colombia,   Estonia,   Guatemala,   Iceland,   India,   Korea, Republic of,   Lithuania,   Malaysia,   Mexico,   Philippines,   Poland,   Puerto Rico,   Romania,   South Africa,   Spain,   Sweden,   United States
Removed Location Countries Costa Rica
 
Administrative Information
NCT Number  ICMJE NCT01081834
Other Study ID Numbers  ICMJE CR017011
28431754DIA3005 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date June 2013

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