Dosage Reduction and Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan

University of Jordan

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Metformin and Glimepiride (Regular Dosage); Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage); Drug: Metformin and Vildagliptin (Regular Dosage); Drug: Metformin and Insulin Glargine U100 (Low Dosage); Drug: Metformin and Glimepiride (Low Dosage); Drug: Metformin and Vildagliptin (Low Dosage); Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage); Drug: Metformin and Insulin Glargine U100 (Regular Dosage)

Study type: Interventional

Funder types: Other

Identifiers

NCT04237493

671201612222

Details and patient eligibility

About

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.

Enrollment: 687 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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687 participants in 2 patient groups

Low-dosage therapy

Experimental group

Treatment:

Drug: Metformin and Insulin Glargine U100 (Low Dosage)

Drug: Metformin and Vildagliptin (Low Dosage)

Drug: Metformin and Glimepiride (Low Dosage)

Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)

Regular-dosage therapy

Active Comparator group

Treatment:

Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage)

Drug: Metformin and Vildagliptin (Regular Dosage)

Drug: Metformin and Glimepiride (Regular Dosage)

Drug: Metformin and Insulin Glargine U100 (Regular Dosage)