Clinical trial NCT02737657: An Observational Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea in Type 2 Diabetes Patients During Ramadan
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Canagliflozin
Metformin
Diabetes Mellitus, Type 2
INVOKANA
Sulfonylurea
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2016-04-14
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a confirmed diagnosis of type 2 diabetes and has been treated with canagliflozin or any sulphonylurea, each on a background therapy of metformin with or without a DPP-4 inhibitor, will be enrolled in this study.

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 percentage of patients with at least one episode of hypoglycaemia, in patients with T2DM who fast during Ramadan.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With at Least one Episode of Hypoglycaemia
timeFrame: during the Ramadan period (up to 1 month)
Secondary outcomes:
measure: Number of Participants With Volume Depletion Events
timeFrame: during the Ramadan period (up to 1 month)
measure: Treatment Adherence Based on the Percentage of Prescribed Doses of Canagliflozin or Sulphonylurea Taken by Participants
timeFrame: during the Ramadan period (up to 1 month)
measure: Time to the First Hypoglycaemia Event
timeFrame: during the Ramadan period (up to 1 month)
measure: Relationship of Hypoglycaemia Events With Clinical Parameters
timeFrame: during the Ramadan period (up to 1 month)
measure: Relationship of Hypoglycaemia Events With Used Treatment
timeFrame: during the Ramadan period (up to 1 month)
measure: Relationship of Hypoglycaemia Events With Treatment Adherence
timeFrame: during the Ramadan period (up to 1 month)
measure: Relationship of Hypoglycaemia Events With Number of Fasting Days
timeFrame: during the Ramadan period (up to 1 month)
measure: Relationship of Volume Depletion Events With Clinical Parameters
timeFrame: during the Ramadan period (up to 1 month)
measure: Relationship of Volume Depletion Events With Used Treatment
timeFrame: during the Ramadan period (up to 1 month)
measure: Relationship of Volume Depletion Events With Treatment Adherence
timeFrame: during the Ramadan period (up to 1 month)
measure: Relationship of Volume Depletion Events With Number of Fasting Days
timeFrame: during the Ramadan period (up to 1 month)
Other outcomes:
Locations:
city: Kuwait City
country: Kuwait
city: Amioun
country: Lebanon
city: Beirut
country: Lebanon
city: Nabatieh
country: Lebanon
city: Saida
country: Lebanon
city: Taalabya
country: Lebanon
city: Tripoli
country: Lebanon
city: Al Ain
country: United Arab Emirates
city: Dubai
country: United Arab Emirates
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Hassanein M, Echtay A, Hassoun A, Alarouj M, Afandi B, Poladian R, Bennakhi A, Nazar M, Bergmans P, Keim S, Hamilton G, Azar ST. Tolerability of canagliflozin in patients with type 2 diabetes mellitus fasting during Ramadan: Results of the Canagliflozin in Ramadan Tolerance Observational Study (CRATOS). Int J Clin Pract. 2017 Oct;71(10):e12991. doi: 10.1111/ijcp.12991. Epub 2017 Aug 29.