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Register:	ClinicalTrials.gov
Last refreshed on:	28 November 2016
Main ID:	NCT02737657
Date of registration:	23/03/2016
Prospective Registration:	Yes
Primary sponsor:	Janssen-Cilag International NV
Public title:	An Observational Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea in Type 2 Diabetes Patients During Ramadan CRATOS
Scientific 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
Date of first enrolment:	April 2016
Target sample size:	379
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02737657
Study type:	Observational
Study design:	Observational Model: Cohort, Time Perspective: Prospective
Phase:

Countries of recruitment
Kuwait	Lebanon	United Arab Emirates

Contacts

Name:	Janssen-Cilag International NV Clinical Trial
Address:
Telephone:
Email:
Affiliation:	Janssen-Cilag International NV

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Primary Outcome(s)

Percentage of Participants With at Least one Episode of Hypoglycaemia [Time Frame: during the Ramadan period (up to 1 month)]

Secondary Outcome(s)

Time to the First Hypoglycaemia Event [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)]

Relationship of Hypoglycaemia Events With Clinical Parameters [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 Hypoglycaemia Events With Used Treatment [Time Frame: during the Ramadan period (up to 1 month)]

Number of Participants With Volume Depletion Events [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 Treatment Adherence [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 Volume Depletion Events With Number of Fasting Days [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)]

Secondary ID(s)

28431754DIA4016

CR108100

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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