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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA4016 | Other Identifier | Janssen-Cilag International |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuwait City | Kuwait | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28851109 | Derived | 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. |
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| Time to the First Hypoglycaemia Event | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | during the Ramadan period (up to 1 month) |
| Amioûn |
| Lebanon |
| Beirut | Lebanon |
| Nabatieh | Lebanon |
| Saida | Lebanon |
| Taalabya | Lebanon |
| Tripoli | Lebanon |
| Al Ain City | United Arab Emirates |
| Dubai | United Arab Emirates |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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