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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

687 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-14

Study Completion Date

2017-07-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low-dosage therapy

Group Type EXPERIMENTAL

Metformin and Glimepiride (Low Dosage)

Intervention Type DRUG

* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\])
* Glimepiride (PO; 1.5 or 3 mg \[75% of the pre-Ramadan dose\]; OD \[with Ifṭār\])

Metformin and Vildagliptin (Low Dosage)

Intervention Type DRUG

* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\])
* Vildagliptin (PO; 50 mg; OD \[with Ifṭār\])

Metformin and Insulin Glargine U100 (Low Dosage)

Intervention Type DRUG

* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\])
* Insulin Glargine U100 (SC; 9-33 units \[75% of the pre-Ramadan dose\]; OD \[at 10 P.M.\])

Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)

Intervention Type DRUG

* 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 \[75% of the pre-Ramadan doses\])

Regular-dosage therapy

Group Type ACTIVE_COMPARATOR

Metformin and Glimepiride (Regular Dosage)

Intervention Type DRUG

* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\])
* Glimepiride (PO; 2 or 4 mg \[100% of the pre-Ramadan dose\]; OD \[with Ifṭār\])

Metformin and Vildagliptin (Regular Dosage)

Intervention Type DRUG

* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\])
* Vildagliptin (PO; 50 mg; BID \[with Ifṭār and with Suḥūr\]\])

Metformin and Insulin Glargine U100 (Regular Dosage)

Intervention Type DRUG

* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\])
* Insulin Glargine U100 (SC; 11-44 units \[100% of the pre-Ramadan dose\]; OD \[at 10 P.M.\])

Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage)

Intervention Type DRUG

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

Interventions

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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 \[with Ifṭār\])

Intervention Type DRUG

Metformin and Vildagliptin (Low Dosage)

* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\])
* Vildagliptin (PO; 50 mg; OD \[with Ifṭār\])

Intervention Type 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 \[at 10 P.M.\])

Intervention Type 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 \[75% of the pre-Ramadan doses\])

Intervention Type 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 \[with Ifṭār\])

Intervention Type DRUG

Metformin and Vildagliptin (Regular Dosage)

* Metformin (PO; 850 mg; BID \[with Ifṭār and with Suḥūr\])
* Vildagliptin (PO; 50 mg; BID \[with Ifṭār and with Suḥūr\]\])

Intervention Type 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 \[at 10 P.M.\])

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No