Phase 3
Completed N=676
A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea
Source: ClinicalTrials.gov NCT01381900 ↗Enrolled (actual)
676
Serious AEs
1.9%
Results posted
Jan 2014
Primary outcomePrimary: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18 — -0.47; -0.97; -1.06 Percent — p=<0.001
Summary
The purpose of this study is to assess the safety, tolerability, and efficacy of the addition of canagliflozin relative to the addition of placebo in patients with inadequate glycemic control on metformin alone or in combination with a sulphonylurea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18 |
-0.47; -0.97; -1.06 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18 |
-0.40; -1.44; -1.83 | <0.001 sig |
| SECONDARY Percent Change in Body Weight From Baseline to Week 18 |
-0.8; -2.9; -3.1 | <0.001 sig |
| SECONDARY Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18 |
27.8; 49.1; 52.9 | — |
| SECONDARY Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18 |
11.7; 21.6; 25.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with T2DM with inadequate glycemic control on metformin monotherapy or on metformin in combination with an SU at protocol-specified doses and having HbA1c >=7.0% and =270 mg/dL (15 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
- History of a severe hypoglycemic episode within 6 months before screening
- History of or current illness considered to be clinically significant by the investigator
Data sourced from ClinicalTrials.gov (NCT01381900). 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.