| Trial ID: | L6710 |
| Source ID: | NCT04237493
|
| Associated Drug: |
Metformin And Glimepiride (Low Dosage)
|
| Title: |
Dosage Reduction and Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Metformin and Glimepiride (Low Dosage)|DRUG: Metformin and Vildagliptin (Low Dosage)|DRUG: Metformin and Insulin Glargine U100 (Low Dosage)|DRUG: Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)|DRUG: Metformin and Glimepiride (Regular Dosage)|DRUG: Metformin and Vildagliptin (Regular Dosage)|DRUG: Metformin and Insulin Glargine U100 (Regular Dosage)|DRUG: Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage)
|
| Outcome Measures: |
Primary: Hypoglycemia, Incidence of hypoglycemia, 29 days of Ramadan|Hyperglycemia, Incidence of hyperglycemia, 29 days of Ramadan | Secondary: Diabetic ketoacidosis, Incidence of diabetic ketoacidosis, 29 days of Ramadan|Hyperosmolar hyperglycemic state, Incidence of hyperosmolar hyperglycemic state, 29 days of Ramadan
|
| Sponsor/Collaborators: |
Sponsor: University of Jordan
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
687
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2017-02-14
|
| Completion Date: |
2017-07-24
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| Results First Posted: |
|
| Last Update Posted: |
2020-02-11
|
| Locations: |
Jordan University Hospital, Amman, Amman Governorate, 11942, Jordan
|
| URL: |
https://clinicaltrials.gov/show/NCT04237493
|