Diabetes Mellitus, Type 2CRATOSNCT02737657
An Observational Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea in Type 2 Diabetes Patients During Ramadan
An observational study of Diabetes Mellitus, Type 2, run by Janssen-Cilag International NV at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 379 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Apr 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Lebanon6 sites
Study site
Amioûn
Study site
Beirut
Study site
Nabatieh
Study site
Saida
Study site
Taalabya
Study site
Tripoli
United Arab Emirates2 sites
Study site
Al Ain City
Study site
Dubai
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Canagliflozin, Metformin, Diabetes Mellitus, Type 2, INVOKANA, Sulfonylurea
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: during the Ramadan period (up to 1 month)
Secondary outcomes (11)
Number of Participants With Volume Depletion Events
Measured: during the Ramadan period (up to 1 month)
Treatment Adherence Based on the Percentage of Prescribed Doses of Canagliflozin or Sulphonylurea Taken by Participants
Measured: during the Ramadan period (up to 1 month)
Time to the First Hypoglycaemia Event
Measured: during the Ramadan period (up to 1 month)
Relationship of Hypoglycaemia Events With Clinical Parameters
Precipitating factors, symptoms and blood glucose concentration during hypoglycaemia episode will be described.
Measured: during the Ramadan period (up to 1 month)
Relationship of Hypoglycaemia Events With Used Treatment
Causal relationship of hypoglycaemia event to treatment will be evaluated.
Measured: during the Ramadan period (up to 1 month)
Relationship of Hypoglycaemia Events With Treatment Adherence
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.
Measured: during the Ramadan period (up to 1 month)
Relationship of Hypoglycaemia Events With Number of Fasting Days
Number of days when fasting was broken due to hypoglycaemia or hypoglycaemia prevention will be captured.
Measured: during the Ramadan period (up to 1 month)
Relationship of Volume Depletion Events With Clinical Parameters
Precipitating factors, symptoms and blood glucose concentration during volume depletion related adverse events will be described.
Measured: during the Ramadan period (up to 1 month)
Relationship of Volume Depletion Events With Used Treatment
Causal relationship of volume depletion related adverse event to treatment will be evaluated.
Measured: during the Ramadan period (up to 1 month)
Relationship of Volume Depletion Events With Treatment Adherence
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.
Measured: during the Ramadan period (up to 1 month)
Relationship of Volume Depletion Events With Number of Fasting Days
Number of days when fasting was broken due to the volume depletion related adverse event will be reported.
Measured: during the Ramadan period (up to 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737657
- Sponsor's protocol ID
- CR108100
- Other IDs
- 28431754DIA4016
- Acronym
- CRATOS
- Status last verified
- Jan 2025
- First submitted
- 23 Mar 2016
- Last updated
- 3 Feb 2025
- Results posted
- No
Publications
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.
PubMed 28851109
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02737657
- Acronym / sponsor ID
- CRATOS / CR108100
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Canagliflozin, Metformin, Diabetes Mellitus, Type 2, INVOKANA, Sulfonylurea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
11 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Derived from this study: PubMed 28851109Hassanein 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.
- To learn how to participate in this trial please click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Janssen-Cilag International NV at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Lebanon, United Arab Emirates, Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With at Least one Episode of Hypoglycaemia (time frame: during the Ramadan period (up to 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02737657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.