drugset / Trial / NCT02694263
Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen for T2DM During Ramadan
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to determine if the addition of Canagliflozin (Invokana™) therapy to monotherapy of metformin is more effective at achieving the double composite endpoint of a reduction in HbA1c (≥ 0.3%) and weight loss (≥1kg) 3-4 weeks post-Ramadan. The study will also include patients currently on dual therapy, specifically metformin plus a sulphonylurea, pioglitazone or repaglinide to determine whether switching to metformin plus Canagliflozin (Invokana™) is more effective at achieving the composite endpoint compared to those remaining on previous dual therapy. There are a number of secondary outcomes including weight loss, rates of hypoglycaemia, blood pressure and a number of biochemical endpoints.
Timeline
- Start
- 2016-07
- Primary completion
- 2018-09-13
- Completion
- 2018-09-13
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CANAGLIFLOZIN ANHYDROUS | Small molecule | 300 mg | Oral |
| Comparator | Gliclazide | Small molecule | 160 mg | — |
| Comparator | Glimepiride | Small molecule | 4 mg | — |
| Comparator | Pioglitazone | Small molecule | 45 mg | — |
| Comparator | Repaglinide | Small molecule | 4 mg | — |