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

Study Overview
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Metformin and Glimepiride (Low Dosage)
* Drug: Metformin and Vildagliptin (Low Dosage)
* Drug: Metformin and Insulin Glargine U100 (Low Dosage)
* Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)
* Drug: Metformin and Glimepiride (Regular Dosage)
* Drug: Metformin and Vildagliptin (Regular Dosage)
* Drug: Metformin and Insulin Glargine U100 (Regular Dosage)
* Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dosage therapy<br> | Drug: Metformin and Glimepiride (Low Dosage)<br>* 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])<br>Drug: Metformin and Vildagliptin (Low Dosage)<br>* Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr]) Vildagliptin (PO; 50 mg; OD [with Ifṭār])<br>Drug: Metformin and Insulin Glargine U100 (Low Dosage)<br>* 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.])<br>Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)<br>* 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])<br>|
| Active Comparator: Regular-dosage therapy<br> | Drug: Metformin and Glimepiride (Regular Dosage)<br>* 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])<br>Drug: Metformin and Vildagliptin (Regular Dosage)<br>* Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr]) Vildagliptin (PO; 50 mg; BID [with Ifṭār and with Suḥūr]])<br>Drug: Metformin and Insulin Glargine U100 (Regular Dosage)<br>* 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.])<br>Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage)<br>* 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])<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia | Incidence of hypoglycemia | 29 days of Ramadan | 
| Hyperglycemia | Incidence of hyperglycemia | 29 days of Ramadan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetic ketoacidosis | Incidence of diabetic ketoacidosis | 29 days of Ramadan | 
| Hyperosmolar hyperglycemic state | Incidence of hyperosmolar hyperglycemic state | 29 days of Ramadan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Fasting, Hypoglycemic Agents, Hypoglycemia, Hyperglycemia, Diabetic Ketoacidosis, Hyperglycemic Hyperosmolar Nonketotic Coma, Metformin, Glimepiride, Vildagliptin, Insulin Glargine, Insulin, Regular, Human