Skip to main content
OpenTrials
Completed

NCT Number: NCT04237493

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Acid-Base Imbalance Acidosis Behavior Diabetes Complications Diabetes Mellitus Diabetic Coma Diabetic Ketoacidosis Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Hyperglycemia Hyperglycemic Hyperosmolar Nonketotic Coma Hyperinsulinism Hypoglycemia Insulin Resistance Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jordan University Hospital

Amman, Amman Governorate, 11942, Jordan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metformin and Glimepiride (Low Dosage)

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)

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)

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)

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])

Metformin and Glimepiride (Regular Dosage)

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)

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)

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)

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])

Primary outcomes

  1. Hypoglycemia

    Time frame: 29 days of Ramadan

    Incidence of hypoglycemia

  2. Hyperglycemia

    Time frame: 29 days of Ramadan

    Incidence of hyperglycemia

Secondary outcomes

  1. Diabetic ketoacidosis

    Time frame: 29 days of Ramadan

    Incidence of diabetic ketoacidosis

  2. Hyperosmolar hyperglycemic state

    Time frame: 29 days of Ramadan

    Incidence of hyperosmolar hyperglycemic state

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 23, 2020
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.