Phase 3
Completed N=714
A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01106651 ↗Enrolled (actual)
714
Serious AEs
10.8%
Results posted
May 2013
Primary outcomePrimary: Change in HbA1c From Baseline to Week 26 — -0.03; -0.60; -0.73 Percent — p=<0.001
Summary
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 26 |
-0.03; -0.60; -0.73 | <0.001 sig |
| SECONDARY Percentage of Patients With HbA1c <7% at Week 26 |
28.0; 47.7; 58.5 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 |
7.39; -18.1; -20.3 | <0.001 sig |
| SECONDARY Percent Change in Body Weight From Baseline to Week 26 |
-0.1; -2.4; -3.1 | <0.001 sig |
| SECONDARY Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition |
-0.28; -1.87; -2.38 | <0.001 sig |
| SECONDARY Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition |
0.00; -1.03; -1.18 | <0.001 sig |
| SECONDARY Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition |
0.02; -1.04; -1.18 | 0.001 sig |
| SECONDARY Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 |
1.10; -3.52; -6.79 | <0.001 sig |
| SECONDARY Percent Change in Triglycerides From Baseline to Week 26 |
7.7; 2.8; 8.4 | 0.194 |
| SECONDARY Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 |
1.5; 6.8; 6.2 | <0.001 sig |
| SECONDARY Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26 |
0.5; 0.7; 0.2 | — |
| SECONDARY Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26 |
-0.5; -0.7; -0.8 | — |
| SECONDARY Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26 |
-1.0; -0.7; -0.6 | — |
| SECONDARY Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26 |
-0.5; -0.9; -1.0 | — |
Eligibility Criteria
Inclusion Criteria
- All patients must have a diagnosis of T2DM and may be currently treated with a stable regimen of antihyperglycemic agent(s)
- Patients in the study must have a HbA1c between >=7 and <=10.0%
- Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)
Exclusion Criteria
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening
Data sourced from ClinicalTrials.gov (NCT01106651). 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.