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

NCT04237493 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 687

Last updated 2020-02-11

No results posted yet for this study

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

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 \[100% of the pre-Ramadan doses\])

Sponsors & Collaborators

  • University of Jordan

    lead OTHER

Principal Investigators

  • Ayman A. Zayed, MD · The University of Jordan School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2017-07-24
Completion
2017-07-24

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04237493 on ClinicalTrials.gov