Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02025907
First received: December 30, 2013
Last updated: October 28, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Canagliflozin, 100 mg
Drug: Canagliflozin, 300 mg
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Body Weight at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
  • Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]

Enrollment: 218
Study Start Date: February 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canagliflozin (JNJ-28431754)
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.
Drug: Canagliflozin, 100 mg
One 100 mg capsule taken orally (by mouth) once daily.
Drug: Canagliflozin, 300 mg
One 300 mg capsule taken orally (by mouth) once daily.
Placebo Comparator: Placebo
Each participant will receive placebo (inactive medication) once daily for 28 weeks.
Drug: Placebo
One placebo capsule taken orally (by mouth) once daily.

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).
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02025907

  Show 57 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02025907     History of Changes
Other Study ID Numbers: CR103477  2013-004819-40  28431754DIA4004 
Study First Received: December 30, 2013
Results First Received: July 22, 2016
Last Updated: October 28, 2016
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Janssen Research & Development, LLC:
Diabetes Mellitus, Type 2
Canagliflozin
Hemoglobin A1c
Metformin
Sitagliptin
T2DM
JNJ-28431754

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Canagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 08, 2016