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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025907
• Other study ID #: CR103477
• Secondary ID: 2013-004819-4028
• Status: Completed
• Phase: Phase 4
• First received: December 30, 2013
• Last updated: October 28, 2016
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2016
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Canagliflozin, 100 mg
One 100 mg capsule taken orally (by mouth) once daily.
• Canagliflozin, 300 mg
One 300 mg capsule taken orally (by mouth) once daily.
• Placebo
One placebo capsule taken orally (by mouth) once daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26		Baseline and Week 26	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26		Baseline and Week 26	No
Secondary	Percent Change From Baseline in Body Weight at Week 26		Baseline and Week 26	No
Secondary	Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26		Week 26	No
Secondary	Change From Baseline in Systolic Blood Pressure (SBP) at Week 26		Baseline and Week 26	No