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inadequate recruitment
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This study will assess if Sitagliptin addition to metformin or glitazone is better than current sulphonylurea based treatments during Ramadan. The rationale is that Sitagliptin offers metabolic advantages primarily with the low incidence of hypoglycemia over current sulphonylurea based treatments.
To define metabolic alterations during Ramadan:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Sitagliptin 100mg |
|
| 2 | Active Comparator | Sulphonylurea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | tablet, 100mg, once daily, 4 weeks |
| |
| sulphonylurea |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of hypoglycemia | 4 weeks during Ramadan |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight, fasting blood sugar, HbA1c, triglycerides, total cholesterol, LDL-C, HDL-C. CGMS to define glycaemic excursions | 4 weeks during Ramadan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rayaz A Malik, MBChB, PhD | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellcome Trust Clinical Research Facility | Manchester | M13 9NT | United Kingdom |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007003 | Hypoglycemia |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D013453 | Sulfonylurea Compounds |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
sulphonylurea, variable, od or bd, during ramadan |
|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D011719 |
| Pyrazines |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |