drugset / Trial / NCT02694263

Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen for T2DM During Ramadan

NCT02694263

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

Drugs

EvaluationDrugModalityDoseRoute
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