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A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen: The 'Can Do Ramadan' Study
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.
Details
| Lead sponsor | University of Leicester |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 25 |
| Start date | 2016-07 |
| Completion | 2018-09-13 |
Conditions
- Diabetes Mellitus, Type 2
Interventions
- Canagliflozin
- Repaglinide
- Pioglitazone
- Gliclazide
- Glimepiride
Primary outcomes
- HbA1c + weight loss — Baseline and 3-4 weeks post-Ramadan
Double composite endpoint of a change in HbA1c (≥ 0.3%) and weight loss (≥1kg) between baseline and 3-4 weeks post-Ramadan.
Countries
United Kingdom