Phase 4
Completed N=216
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
Source: ClinicalTrials.gov NCT02025907 ↗Enrolled (actual)
216
Serious AEs
1.8%
Results posted
Sep 2016
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 — -0.01; -0.91 percentage of glycosylated hemoglobin
◆ Published Evidence
Emerging
10citations · ~1 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 |
-0.01; -0.91 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 |
-0.14; -1.65 | — |
| SECONDARY Percent Change From Baseline in Body Weight at Week 26 |
-1.60; -3.35 | — |
| SECONDARY Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26 |
12.2; 32.3 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 |
0.09; -5.76 | — |
Eligibility Criteria
Inclusion Criteria
- Must have a diagnosis of type 2 diabetes mellitus
- Must have a screening HbA1c of >=7.5% to =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 =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
Data sourced from ClinicalTrials.gov (NCT02025907) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.