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

January 31, 2025 updated by: Janssen-Cilag International NV

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
379

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kuwait
      • Kuwait City, Kuwait
  • Lebanon
      • Amioun, Lebanon
      • Beirut, Lebanon
      • Nabatieh, Lebanon
      • Saida, Lebanon
      • Taalabya, Lebanon
      • Tripoli, Lebanon
  • United Arab Emirates
      • Al Ain, United Arab Emirates
      • Dubai, United Arab Emirates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With at Least one Episode of Hypoglycaemia
Time Frame: during the Ramadan period (up to 1 month)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Volume Depletion Events
Time Frame: during the Ramadan period (up to 1 month)
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)
during the Ramadan period (up to 1 month)
Time to the First Hypoglycaemia Event
Time Frame: during the Ramadan period (up to 1 month)
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)
Precipitating factors, symptoms and blood glucose concentration during hypoglycaemia episode will be described.
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)
Causal relationship of hypoglycaemia event to treatment will be evaluated.
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)
Treatment adherence will be based on the percentage of prescribed doses of canagliflozin or sulphonylurea that are missed during the Ramadan period, as reported in the patient diary. Any changes in study medication (i.e. missed or delayed dosing) due to hypoglycaemia events will be captured.
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)
Number of days when fasting was broken due to hypoglycaemia or hypoglycaemia prevention will be captured.
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)
Precipitating factors, symptoms and blood glucose concentration during volume depletion related adverse events will be described.
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)
Causal relationship of volume depletion related adverse event to treatment will be evaluated.
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)
Treatment adherence will be based on the percentage of prescribed doses of canagliflozin or sulphonylurea that are missed during the Ramadan period, as reported in the patient diary. Any changes in study medication (i.e. missed or delayed dosing) due to Volume depletion related adverse events will be captured.
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)
Number of days when fasting was broken due to the volume depletion related adverse event will be reported.
during the Ramadan period (up to 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag International NV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen-Cilag International NV Clinical Trial, Janssen-Cilag International NV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108100
  • 28431754DIA4016 (Other Identifier: Janssen-Cilag International)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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