CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Canagliflozin +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02694263
NCT02694263Phase 4Completed

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

University of Leicester·interventional·Posted Feb 29, 2016·Updated Jan 30, 2020

In Brief

A Phase 4 clinical trial evaluating Canagliflozin, Repaglinide, and 3 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 25 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 29, 2016
Enrollment StartJul 1, 2016
Primary CompletionSep 13, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.3 years ago

Interventions

Canagliflozindrug

Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Repaglinide, Pioglitazone, Gliclazide or Glimepiride) for the treatment of Type 2 Diabetes.

Repaglinidedrug

Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Repaglinide) for the treatment of Type 2 Diabetes.

Pioglitazonedrug

Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Pioglitazone) for the treatment of Type 2 Diabetes.

Gliclazidedrug

Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Gliclazide) for the treatment of Type 2 Diabetes.

Glimepiridedrug

Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Glimepiride) for the treatment of Type 2 Diabetes.