An Observational Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea in Type 2 Diabetes Patients During Ramadan

NCT02737657 | Completed

• 2 other identifiers: CR10810028431754DIA4016
• Study Type: observational
• Target: 379
• Locations: 3 countries
• Sites: 9

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Canagliflozin; Metformin; Diabetes Mellitus, Type 2; INVOKANA; Sulfonylurea

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least one Episode of Hypoglycaemia

  Hypoglycaemia events are defined by symptoms (e.g., dizziness, visual blurring, palpitations, nausea, sweating, confusion, tremor or intense hunger) reported by the patient in the patient diary, with confirmation by a physician where applicable; Episode may be documented via a self-monitored blood glucose measurement \<70 milligram/deciliter (mg/dl).

  during the Ramadan period (up to 1 month)

Secondary Outcomes (11)

• Number of Participants With Volume Depletion Events

  during the Ramadan period (up to 1 month)

• Treatment Adherence Based on the Percentage of Prescribed Doses of Canagliflozin or Sulphonylurea Taken by Participants

  during the Ramadan period (up to 1 month)

• Time to the First Hypoglycaemia Event

  during the Ramadan period (up to 1 month)

• Relationship of Hypoglycaemia Events With Clinical Parameters

  during the Ramadan period (up to 1 month)

• Relationship of Hypoglycaemia Events With Used Treatment

  during the Ramadan period (up to 1 month)

Study Arms (2)

Cohort 1

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.

Cohort 2

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (9)

Unknown Facility

Kuwait City, Kuwait

Location

Unknown Facility

Amioûn, Lebanon

Location

Unknown Facility

Beirut, Lebanon

Location

Unknown Facility

Nabatieh, Lebanon

Location

Unknown Facility

Saida, Lebanon

Location

Unknown Facility

Taalabya, Lebanon

Location

Unknown Facility

Tripoli, Lebanon

Location

Unknown Facility

Al Ain City, United Arab Emirates

Location

Unknown Facility

Dubai, United Arab Emirates

Location

Related Publications (1)

• 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.

  PMID: 28851109 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 14, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

LE (6); KU (1); AE (2)