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

PHASE4CompletedINTERVENTIONAL
Enrollment

687

Participants

Timeline

Start Date

February 14, 2017

Primary Completion Date

July 24, 2017

Study Completion Date

July 24, 2017

Conditions
Diabetes Mellitus, Type 2
Interventions
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 \[100% of the pre-Ramadan doses\])"

Trial Locations (1)

11942

Jordan University Hospital, Amman

All Listed Sponsors
lead

University of Jordan

OTHER

NCT04237493 - Dosage Reduction and Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan | Biotech Hunter | Biotech Hunter