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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237493
• Other study ID #: 671201612222
• Status: Completed
• Phase: Phase 4
• Start date: February 14, 2017
• Est. completion date: July 24, 2017

Study information

• Verified date: February 2020
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 687
• Est. completion date: July 24, 2017
• Est. primary completion date: July 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Metformin and Glimepiride (Low Dosage)
Metformin (PO; 850 mg; BID [with If?ar and with Su?ur]) Glimepiride (PO; 1.5 or 3 mg [75% of the pre-Ramadan dose]; OD [with If?ar])
• Metformin and Vildagliptin (Low Dosage)
Metformin (PO; 850 mg; BID [with If?ar and with Su?ur]) Vildagliptin (PO; 50 mg; OD [with If?ar])
• Metformin and Insulin Glargine U100 (Low Dosage)
Metformin (PO; 850 mg; BID [with If?ar and with Su?ur]) Insulin Glargine U100 (SC; 9-33 units [75% of the pre-Ramadan dose]; OD [at 10 P.M.])
• Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)
Metformin (PO; 850 mg; BID [with If?ar and with Su?ur]) Insulin Glargine U100 (SC; 6-39 units (75% of the pre-Ramadan dose); OD [at 10 P.M.]) Human Regular Insulin (SC; 15-33 units before If?ar and 6-18 units before Su?ur [75% of the pre-Ramadan doses])
• Metformin and Glimepiride (Regular Dosage)
Metformin (PO; 850 mg; BID [with If?ar and with Su?ur]) Glimepiride (PO; 2 or 4 mg [100% of the pre-Ramadan dose]; OD [with If?ar])
• Metformin and Vildagliptin (Regular Dosage)
Metformin (PO; 850 mg; BID [with If?ar and with Su?ur]) Vildagliptin (PO; 50 mg; BID [with If?ar and with Su?ur]])
• Metformin and Insulin Glargine U100 (Regular Dosage)
Metformin (PO; 850 mg; BID [with If?ar and with Su?ur]) Insulin Glargine U100 (SC; 11-44 units [100% of the pre-Ramadan dose]; OD [at 10 P.M.])
• Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage)
Metformin (PO; 850 mg; BID [with If?ar and with Su?ur]) Insulin Glargine U100 (SC; 8-52 units (100% of the pre-Ramadan dose); OD [at 10 P.M.]) Human Regular Insulin (SC; 12-40 units before If?ar and 7-28 units before Su?ur [100% of the pre-Ramadan doses])

Locations

Country	Name	City	State
Jordan	Jordan University Hospital	Amman	Amman Governorate

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoglycemia	Incidence of hypoglycemia	29 days of Ramadan
Primary	Hyperglycemia	Incidence of hyperglycemia	29 days of Ramadan
Secondary	Diabetic ketoacidosis	Incidence of diabetic ketoacidosis	29 days of Ramadan
Secondary	Hyperosmolar hyperglycemic state	Incidence of hyperosmolar hyperglycemic state	29 days of Ramadan