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The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Canagliflozin
Placebo
Sitagliptin
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Canagliflozin, Placebo, Hemoglobin A1c, Type 2 diabetes mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Canagliflozin 100 mg

Canagliflozin 300 mg

Placebo/Sitagliptin

Arm Description

Each patient will receive 100 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).

Each patient will receive 300 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).

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.

Outcomes

Primary Outcome Measures

Change in HbA1c From Baseline to Week 26 (Main Study)
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)
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.

Secondary Outcome Measures

Percentage of Patients With HbA1c <7% at Week 26 (Main Study)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.

Full Information

First Posted
March 4, 2010
Last Updated
February 15, 2017
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01081834
Brief Title
The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2, Canagliflozin, Placebo, Hemoglobin A1c, Type 2 diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
678 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canagliflozin 100 mg
Arm Type
Experimental
Arm Description
Each patient will receive 100 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).
Arm Title
Canagliflozin 300 mg
Arm Type
Experimental
Arm Description
Each patient will receive 300 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).
Arm Title
Placebo/Sitagliptin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Canagliflozin
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One matching placebo capsule orally once daily for 26 weeks (Main Study)
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 (Main Study)
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline to Week 26 (Main Study)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26
Title
Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26
Secondary Outcome Measure Information:
Title
Percentage of Patients With HbA1c <7% at Week 26 (Main Study)
Description
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.
Time Frame
Week 26
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (Main Study)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26
Title
Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26
Title
Percent Change in Body Weight From Baseline to Week 26 (Main Study)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26
Title
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26
Title
Percent Change in Triglycerides From Baseline to Week 26 (Main Study)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26
Title
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26
Title
Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)
Description
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.
Time Frame
Week 26
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26
Title
Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26
Title
Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26
Title
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26
Title
Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26
Title
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy)
Description
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.
Time Frame
Day 1 (Baseline) and Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Concord
State/Province
California
Country
United States
City
Greenbrae
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Spring Valley
State/Province
California
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Northglenn
State/Province
Colorado
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Baton Rouge
State/Province
Louisiana
Country
United States
City
Metairie
State/Province
Louisiana
Country
United States
City
Meridian
State/Province
New Jersey
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
New York
State/Province
New York
Country
United States
City
West Seneca
State/Province
New York
Country
United States
City
Mooresville
State/Province
North Carolina
Country
United States
City
Perryopolis
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Taylors
State/Province
South Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Horn
Country
Austria
City
Salzburg
Country
Austria
City
Wien
Country
Austria
City
Barranquilla
Country
Colombia
City
Bogota
Country
Colombia
City
Pärnu
Country
Estonia
City
Tartu
Country
Estonia
City
Viljandi
Country
Estonia
City
Guatemala
Country
Guatemala
City
Reykjavik
Country
Iceland
City
Bangalore
Country
India
City
Hyderabad
Country
India
City
Nagpur
Country
India
City
Busan
Country
Korea, Republic of
City
Goyang-Si
Country
Korea, Republic of
City
Jeonju-Si
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Wonju-Si
Country
Korea, Republic of
City
Kaunas
Country
Lithuania
City
Klaipeda
Country
Lithuania
City
Siauliai
Country
Lithuania
City
Vilnius Lt
Country
Lithuania
City
Vilnius
Country
Lithuania
City
Kelantan
Country
Malaysia
City
Kuala Lumpur N/A
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Aguascalientes
Country
Mexico
City
Guadalajara
Country
Mexico
City
Mex
Country
Mexico
City
Monterrey
Country
Mexico
City
Zapopan
Country
Mexico
City
Makati
Country
Philippines
City
Manila
Country
Philippines
City
Marikina City
Country
Philippines
City
Pasay
Country
Philippines
City
Katowice
Country
Poland
City
Torun
Country
Poland
City
Warszawa
Country
Poland
City
Fajardo
Country
Puerto Rico
City
Ponce
Country
Puerto Rico
City
San Juan
Country
Puerto Rico
City
Baia Mare
Country
Romania
City
Brasov
Country
Romania
City
Bucharest
Country
Romania
City
Targu Mures
Country
Romania
City
Halfway
Country
South Africa
City
Pretoria
Country
South Africa
City
Alcala De Henares
Country
Spain
City
Elche
Country
Spain
City
Girona
Country
Spain
City
Pozuelo De Alarcon
Country
Spain
City
Göteborg
Country
Sweden
City
Lund
Country
Sweden
City
Malmö
Country
Sweden
City
Skene
Country
Sweden

12. IPD Sharing Statement

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Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.
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John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.
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Citation
Stenlof K, Cefalu WT, Kim KA, Jodar E, Alba M, Edwards R, Tong C, Canovatchel W, Meininger G. Long-term efficacy and safety of canagliflozin monotherapy in patients with type 2 diabetes inadequately controlled with diet and exercise: findings from the 52-week CANTATA-M study. Curr Med Res Opin. 2014 Feb;30(2):163-75. doi: 10.1185/03007995.2013.850066. Epub 2013 Oct 28.
Results Reference
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The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

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