NCT04237493

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 687 (actual)
• Sponsor: University of Jordan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Metformin and Glimepiride (Low Dosage)	* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\]) * Glimepiride (PO; 1.5 or 3 mg \[75% of the pre-Ramadan dose\]; OD \[with Ifṭār\])
DRUG	Metformin and Vildagliptin (Low Dosage)	* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\]) * Vildagliptin (PO; 50 mg; OD \[with Ifṭār\])
DRUG	Metformin and Insulin Glargine U100 (Low Dosage)	* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\]) * Insulin Glargine U100 (SC; 9-33 units \[75% of the pre-Ramadan dose\]; OD \[at 10 P.M.\])
DRUG	Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)	* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\]) * 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 Ifṭār and 6-18 units before Suḥūr \[75% of the pre-Ramadan doses\])
DRUG	Metformin and Glimepiride (Regular Dosage)	* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\]) * Glimepiride (PO; 2 or 4 mg \[100% of the pre-Ramadan dose\]; OD \[with Ifṭār\])
DRUG	Metformin and Vildagliptin (Regular Dosage)	* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\]) * Vildagliptin (PO; 50 mg; BID \[with Ifṭār and with Suḥūr\]\])
DRUG	Metformin and Insulin Glargine U100 (Regular Dosage)	* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\]) * Insulin Glargine U100 (SC; 11-44 units \[100% of the pre-Ramadan dose\]; OD \[at 10 P.M.\])
DRUG	Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage)	* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\]) * 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 Ifṭār and 7-28 units before Suḥūr \[100% of the pre-Ramadan doses\])

Timeline

• Start date: 2017-02-14
• Primary completion: 2017-07-24
• Completion: 2017-07-24
• First posted: 2020-01-23
• Last updated: 2020-02-11

Locations

1 site across 1 country: Jordan