Efficacy of Educational Nutrition and Exercise on the Regulation of Appetite Through Exosomes in Type 2 Diabetics
NCT05259449
Diabetes Mellitus, Diabetes Mellitus, Type 2
Puerto Real, Cadiz, Spain
View Trial DetailsNCT Number: NCT02737657
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.
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Notify Me18 year–65 year
All sexes
Observational
Kuwait City, Kuwait
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: during the Ramadan period (up to 1 month)
Time frame: during the Ramadan period (up to 1 month)
Time frame: during the Ramadan period (up to 1 month)
Time frame: during the Ramadan period (up to 1 month)
Precipitating factors, symptoms and blood glucose concentration during hypoglycaemia episode will be described.
Time frame: during the Ramadan period (up to 1 month)
Causal relationship of hypoglycaemia event to treatment will be evaluated.
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.
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.
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.
Time frame: during the Ramadan period (up to 1 month)
Causal relationship of volume depletion related adverse event to treatment will be evaluated.
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.
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.
Janssen-Cilag International NV
Industry
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
Acronym: CRATOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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