Phase 3
Completed N=1,186
A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise
Source: ClinicalTrials.gov NCT01809327 ↗Enrolled (actual)
1,186
Serious AEs
2.5%
Results posted
Jan 2016
Primary outcomePrimary: Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26 — -1.30; -1.37; -1.42; -1.77 percentage of hemoglobin — p=0.001
Summary
The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise. The safety and tolerability of canagliflozin will also be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26 |
-1.30; -1.37; -1.42; -1.77; -1.78 | 0.001 sig |
| SECONDARY Percent Change in Body Weight From Baseline to Week 26 |
-2.1; -3.0; -3.9; -3.5; -4.2 | 0.016 sig |
| SECONDARY Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26 |
43.0; 38.8; 42.8; 49.6; 56.8 | 0.027 sig |
| SECONDARY Change in Systolic Blood Pressure From Baseline at Week 26 |
-0.33; -2.24; -2.36; -2.24; -1.65 | 0.060 |
| SECONDARY Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 |
10.2; 17.6; 16.6; 15.5; 14.5 | 0.147 |
| SECONDARY Percent Change in Triglycerides From Baseline to Week 26 |
13.6; 1.7; 2.8; 13.0; 21.2 | 0.608 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) |
89; 88; 95; 99; 105 | — |
Eligibility Criteria
Inclusion Criteria
- Must have type 2 diabetes mellitus with inadequate glycemic control on diet and exercise
- Not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have a screening visit fingerstick glycated hemoglobin (HbA1c) of more than or equal to 7 percent and less than or equal to 12.5 percent
- Have a screening visit HbA1c of more than or equal to 7.5 percent and less than or equal to 12 percent as determined by the central laboratory
- Must have a fasting plasma glucose of less than or equal to 300 mg/dL (16.7 mmol/L) prior to randomization
- Must have a fasting fingerstick glucose of greater than 120 mg/dL (6.7 mmol/L) performed at home or at the study center prior to randomization
Exclusion Criteria
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- Fasting C-peptide less than 0.70 ng/mL (0.23 nmol/L) in participants for whom the investigator cannot reasonably exclude T1DM based upon clinical evaluation
- Repeated (2 or more over a 1 week period) fasting self-monitored blood glucose measurements more than 300 mg/dL (16.7 mmol/L) prior to randomization, despite reinforcement of diet and exercise counseling
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- Has history of, or currently active, illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
Data sourced from ClinicalTrials.gov (NCT01809327). 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.