Status:
COMPLETED
An Observational Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea in Type 2 Diabetes Patients During Ramadan
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-65 years
Brief 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 percentag...
Detailed Description
This is non-randomized, parallel-cohort, prospective, multicenter (when more than one hospital works on a medical research study), observational study to describe the treatment of T2DM with canagliflo...
Eligibility Criteria
Inclusion
- 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
- 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 has heart failure (NYHA 3-4) or advanced cardiovascular disease.
- Participants who has an estimated glomerular filtration rate (eGFR) less than (\<) 60 milliliter/minute (mL/min)/1.73 m\^2.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT02737657
Start Date
April 1 2016
End Date
September 1 2016
Last Update
February 3 2025
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Kuwait City, Kuwait
2
Amioûn, Lebanon
3
Beirut, Lebanon
4
Nabatieh, Lebanon