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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Metformin and Glimepiride (Regular Dosage); Drug: Metformin and Glimepiride (Low Dosage); Drug: Metformin and Vildagliptin (Regular Dosage); Drug: Metformin and Vildagliptin (Low Dosage); Drug: Metformin and Insulin Glargine U100 (Regular Dosage); Drug: Metformin and Insulin Glargine U100 (Low Dosage); Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage); Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)

• Registration Number: NCT04237493
• Lead Sponsor: University of Jordan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-14
• Primary Completion: 2017-07-24
• Study Completion: 2017-07-24
• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-23
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-09
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 687

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regular-dosage therapy	Metformin and Vildagliptin (Regular Dosage)	-
Low-dosage therapy	Metformin and Vildagliptin (Low Dosage)	-
Regular-dosage therapy	Metformin and Glimepiride (Regular Dosage)	-
Regular-dosage therapy	Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage)	-
Regular-dosage therapy	Metformin and Insulin Glargine U100 (Regular Dosage)	-
Low-dosage therapy	Metformin and Glimepiride (Low Dosage)	-
Low-dosage therapy	Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)	-
Low-dosage therapy	Metformin and Insulin Glargine U100 (Low Dosage)	-

Primary Outcome Measures

Name	Time	Method
Hyperglycemia	29 days of Ramadan	Incidence of hyperglycemia
Hypoglycemia	29 days of Ramadan	Incidence of hypoglycemia

Secondary Outcome Measures

Name	Time	Method
Diabetic ketoacidosis	29 days of Ramadan	Incidence of diabetic ketoacidosis
Hyperosmolar hyperglycemic state	29 days of Ramadan	Incidence of hyperosmolar hyperglycemic state

Trial Locations

Locations (1)

Jordan University Hospital; 🇯🇴 Amman, Amman Governorate, Jordan