An Observational Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea in Type 2 Diab… (NCT02737657) | Clinical Trial Compass
CompletedNot Applicable
An Observational Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea in Type 2 Diabetes Patients During Ramadan
Kuwait, Lebanon379 participantsStarted 2016-04
Plain-language summary
The primary purpose of this study is to describe the tolerability of canagliflozin and any sulphonylurea (each administered with metformin with or without a DPP-4 inhibitor), in terms of the percentage of patients with at least one episode of hypoglycaemia, in patients with T2DM who fast during Ramadan.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Participants who has a confirmed diagnosis of type 2 diabetes for more than 12 months before enrollment
* Participants who has been treated with canagliflozin or any sulphonylurea, each on a background therapy of metformin with or without a dipeptidyl peptidase 4 (DPP-4) inhibitor, for \>12 weeks before enrollment
* Participants Intends to fast during Ramadan in 2016
* Participants Will be able to continue on the products under study (i.e., canagliflozin or any sulphonylurea, each with metformin with or without a DPP-4 inhibitor) through the Ramadan period, as judged by the participating physician
* Participants who has a glycated hemoglobin (HbA1c) measurement less than and equal to (\<=) 8.5% within 8 weeks before the start of Ramadan.
Exclusion Criteria:
* Participant is being treated with insulin and/or any type 2 diabetes mellitus (T2DM) therapy other than canagliflozin, any sulphonylurea, and metformin with or without a DPP 4 inhibitor, or has changed their T2DM therapy within 12 weeks before enrollment (dose changes of canagliflozin, a sulphonylurea, metformin, and a DPP 4 inhibitor where applicable are accepted)
* Participant is currently being treated with loop diuretics
* Participants who has a history of severe hypoglycaemia events within the 6 months prior to enrollment (defined as a hypoglycaemia event for which the patient required assistance from another person, or which resulted in seizure or loss of consciousness).
* Participants who …
What they're measuring
1
Percentage of Participants With at Least one Episode of Hypoglycaemia
Timeframe: during the Ramadan period (up to 1 month)