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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04237493

Enrollment

687

Registered

2020-01-23

Start date

2017-02-14

Completion date

2017-07-24

Last updated

2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2, Fasting, Hypoglycemic Agents, Hypoglycemia, Hyperglycemia, Diabetic Ketoacidosis, Hyperglycemic Hyperosmolar Nonketotic Coma, Metformin, Glimepiride, Vildagliptin, Insulin Glargine, Insulin, Regular, Human

Brief 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.

Interventions

DRUGMetformin 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 \[with Ifṭār\])

DRUGMetformin and Vildagliptin (Low Dosage)

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

DRUGMetformin 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 \[at 10 P.M.\])

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

DRUGMetformin 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 \[with Ifṭār\])

DRUGMetformin and Vildagliptin (Regular Dosage)

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

DRUGMetformin 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 \[at 10 P.M.\])

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Hypoglycemia	29 days of Ramadan	Incidence of hypoglycemia
Hyperglycemia	29 days of Ramadan	Incidence of hyperglycemia

Secondary

Measure	Time frame	Description
Diabetic ketoacidosis	29 days of Ramadan	Incidence of diabetic ketoacidosis
Hyperosmolar hyperglycemic state	29 days of Ramadan	Incidence of hyperosmolar hyperglycemic state

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026