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A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Canagliflozin, 100 mg
Canagliflozin, 300 mg
Placebo
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, Hemoglobin A1c, Metformin, Sitagliptin, T2DM, JNJ-28431754

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must have a diagnosis of type 2 diabetes mellitus
  • Must have a screening HbA1c of >=7.5% to <=10.5%
  • Must be on metformin >=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed dose combination) at a stable dose for at least 12 weeks before screening

Exclusion Criteria:

  • History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption or primary renal glycosuria
  • A myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before screening
  • eGFR <60 ml/min/1.73m2, or serum creatinine >=1.4 mg/dL for men and >=1.3 mg/dL for women
  • Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis)
  • Major surgery (ie, requiring general anesthesia) within 12 weeks before screening

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Canagliflozin (JNJ-28431754)

Placebo

Arm Description

Each participant will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 6 weeks, then the dose may be increased to 300 mg once daily.

Each participant will receive placebo (inactive medication) once daily for 28 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26

Secondary Outcome Measures

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Percent Change From Baseline in Body Weight at Week 26
Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26
Change From Baseline in Systolic Blood Pressure (SBP) at Week 26

Full Information

First Posted
December 30, 2013
Last Updated
October 28, 2016
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02025907
Brief Title
A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin
Official Title
A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.
Detailed Description
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a study drug, to test whether the study drug has a real effect), multicenter study of efficacy, safety, and tolerability of canagliflozin in participants with T2DM, who have inadequate glycemic (blood sugar) control on maximally or near-maximally effective doses of metformin >=1500 mg/day and sitagliptin 100 mg/day. Approximately 200 participants will be randomly assigned to 1 of 2 treatment groups in 1:1 ratio for 26 weeks. During the study the participants will be also provided with diet and exercise counseling (standardized non-pharmacological therapy).

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, Hemoglobin A1c, Metformin, Sitagliptin, T2DM, JNJ-28431754

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canagliflozin (JNJ-28431754)
Arm Type
Experimental
Arm Description
Each participant will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 6 weeks, then the dose may be increased to 300 mg once daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Each participant will receive placebo (inactive medication) once daily for 28 weeks.
Intervention Type
Drug
Intervention Name(s)
Canagliflozin, 100 mg
Intervention Description
One 100 mg capsule taken orally (by mouth) once daily.
Intervention Type
Drug
Intervention Name(s)
Canagliflozin, 300 mg
Intervention Description
One 300 mg capsule taken orally (by mouth) once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One placebo capsule taken orally (by mouth) once daily.
Primary Outcome Measure Information:
Title
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Time Frame
Baseline and Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Time Frame
Baseline and Week 26
Title
Percent Change From Baseline in Body Weight at Week 26
Time Frame
Baseline and Week 26
Title
Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26
Time Frame
Week 26
Title
Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
Time Frame
Baseline and Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have a diagnosis of type 2 diabetes mellitus Must have a screening HbA1c of >=7.5% to <=10.5% Must be on metformin >=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed dose combination) at a stable dose for at least 12 weeks before screening Exclusion Criteria: History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption or primary renal glycosuria A myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before screening eGFR <60 ml/min/1.73m2, or serum creatinine >=1.4 mg/dL for men and >=1.3 mg/dL for women Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis) Major surgery (ie, requiring general anesthesia) within 12 weeks 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
Montgomery
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Northridge
State/Province
California
Country
United States
City
Norwalk
State/Province
California
Country
United States
City
Rancho Cucamonga
State/Province
California
Country
United States
City
San Ramon
State/Province
California
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Littleton
State/Province
Colorado
Country
United States
City
Cooper City
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
North Miami Beach
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Perry
State/Province
Georgia
Country
United States
City
Shawnee Mission
State/Province
Kansas
Country
United States
City
Marrero
State/Province
Louisiana
Country
United States
City
Metairie
State/Province
Louisiana
Country
United States
City
Metarie
State/Province
Louisiana
Country
United States
City
Rockville
State/Province
Maryland
Country
United States
City
Jackson
State/Province
Mississippi
Country
United States
City
Picayune
State/Province
Mississippi
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Nashua
State/Province
New Hampshire
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Albany
State/Province
New York
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Sugarland
State/Province
Texas
Country
United States
City
Bountiful
State/Province
Utah
Country
United States
City
Coffs Harbour
Country
Australia
City
Freemantle
Country
Australia
City
Geelong
Country
Australia
City
Heidelberg
Country
Australia
City
Herston
Country
Australia
City
Melbourne
Country
Australia
City
Merewether
Country
Australia
City
Sherwood
Country
Australia
City
Sydney
Country
Australia
City
Wollongong
Country
Australia
City
Brampton
State/Province
Ontario
Country
Canada
City
Hawkesbury
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
La Rochelle Cedex 1 Poitou-Cha
Country
France
City
La Tronche
Country
France
City
Nancy
Country
France
City
Narbonne Cedex
Country
France
City
Nice Cedex 3
Country
France
City
Paris Cedex 15
Country
France
City
Venissieux
Country
France
City
Freiburg
Country
Germany
City
Fulda
Country
Germany
City
Hamburg
Country
Germany
City
Münster
Country
Germany
City
Neuwied
Country
Germany
City
Pirna
Country
Germany
City
Speyer
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29313267
Citation
Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.
Results Reference
derived

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin

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