Dosage Reduction and Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan
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Every lunar year, during the month of Ramadan, Muslims abstain from food and drink between dawn and nightfall. People with type 2 diabetes who fast during Ramadan are at an increased risk of acute glycemic complications. Our aim is to investigate the effect of dosage reduction of four glucose-lowering multidrug regimens on the incidence of acute glycemic complications in people with type 2 diabetes who fast during Ramadan.
Condition or disease
Diabetes Mellitus, Type 2
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)
Effect of Dosage Reduction of Glucose-Lowering Multidrug Regimens on the Incidence of Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan: An Open-Label, Parallel-Group, Randomized, Controlled Trial
Actual Study Start Date :
February 14, 2017
Actual Primary Completion Date :
July 24, 2017
Actual Study Completion Date :
July 24, 2017
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Prospective participant is a returning patient with type 2 diabetes;
Prospective participant expressed an intention to fast during Ramadan;
Prospective participant has been compliant with one of four glucose-lowering multidrug regimens for at least the past three months.
Prospective participant is a pregnant, postpartum, breastfeeding, or eumenorrheic woman;
Prospective participant has experienced diabetic ketoacidosis or hyperosmolar hyperglycemic state within three months;
Prospective participant has received niacin or corticosteroids within one month; and,
Prospective participant has any history of recurrent hypoglycemia, hypoglycemia unawareness, chronic renal insufficiency (stages IV or V), liver cirrhosis, uncontrolled epilepsy, depressive disorder, bipolar disorder, psychotic disorder, or cognitive dysfunction.