Phase 4
Completed N=143
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02622113 ↗Enrolled (actual)
143
Serious AEs
9.9%
Results posted
Mar 2019
Primary outcomePrimary: Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) — 7; 7; 57; 69 Participants
◆ Published Evidence
Emerging
14citations · ~2 / year
Long-term efficacy and safety of canagliflozin in combination with insulin in Japanese patients with type 2 diabetes mellitus.
Summary
This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)
Linked Publications
-
Long-term efficacy and safety of canagliflozin in combination with insulin in Japanese patients with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) |
7; 7; 57; 69 | — |
| SECONDARY Change in Percentage of HbA1c |
-1.09; -0.88 | — |
| SECONDARY Change in Fasting Plasma Glucose |
-33.1; -32.8 | — |
| SECONDARY Percentage Change in Body Weight |
-1.40; -2.14 | — |
Eligibility Criteria
Inclusion Criteria
- Patients should complete the week 16 assessments in the double-blind study (TA-7284-11)
Exclusion Criteria
- Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
- Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
- Patients with serious renal or hepatic disease
- Patients who are the excessive alcohol addicts
- Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception
Data sourced from ClinicalTrials.gov (NCT02622113) 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.