Overview

This trial has been completed.

Condition diabetes mellitus, type 2
Phase phase 4
Sponsor Janssen-Cilag International NV
Start date April 2016
End date September 2016
Trial size 379 participants
Trial identifier NCT02737657, 28431754DIA4016, CR108100

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Participants who are already receiving Canagliflozin and Metformin with or without a DPP-4 inhibitor daily during Ramadan period will be observed as the part of study.
Participants who are already receiving any sulphonylurea and Metformin with or without a DPP-4 inhibitor daily during Ramadan period will be observed as a part of study.

Primary Outcomes

Measure
Percentage of Participants With at Least one Episode of Hypoglycaemia
time frame: during the Ramadan period (up to 1 month)

Secondary Outcomes

Measure
Number of Participants With Volume Depletion Events
time frame: during the Ramadan period (up to 1 month)
Treatment Adherence Based on the Percentage of Prescribed Doses of Canagliflozin or Sulphonylurea Taken by Participants
time frame: during the Ramadan period (up to 1 month)
Time to the First Hypoglycaemia Event
time frame: during the Ramadan period (up to 1 month)
Relationship of Hypoglycaemia Events With Clinical Parameters
time frame: during the Ramadan period (up to 1 month)
Relationship of Hypoglycaemia Events With Used Treatment
time frame: during the Ramadan period (up to 1 month)
Relationship of Hypoglycaemia Events With Treatment Adherence
time frame: during the Ramadan period (up to 1 month)
Relationship of Hypoglycaemia Events With Number of Fasting Days
time frame: during the Ramadan period (up to 1 month)
Relationship of Volume Depletion Events With Clinical Parameters
time frame: during the Ramadan period (up to 1 month)
Relationship of Volume Depletion Events With Used Treatment
time frame: during the Ramadan period (up to 1 month)
Relationship of Volume Depletion Events With Treatment Adherence
time frame: during the Ramadan period (up to 1 month)
Relationship of Volume Depletion Events With Number of Fasting Days
time frame: during the Ramadan period (up to 1 month)

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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 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.

Additional Information

Official title Observational, Prospective, Parallel Cohort Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea on a Background Therapy of Metformin With or Without a DPP-4 Inhibitor During Ramadan Fasting in Patients With Type 2 Diabetes
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 canagliflozin during the Holy Month of Ramadan. Observed participants will be participants with T2DM (at the time of enrollment) who are being treated with either canagliflozin or any sulphonylurea, each administered on a background therapy of metformin with or without a DPP-4 inhibitor within clinical practice, and who intend to fast during the Ramadan period. On enrollment, patients will enter one of two parallel treatment cohorts based on their ongoing T2DM therapy: canagliflozin and metformin with or without a DPP-4 inhibitor will be the treatment of interest, while any sulphonylurea and metformin with or without a DPP-4 inhibitor will serve as the reference standard treatment. Safety will be monitored throughout the study.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Janssen-Cilag International NV.