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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04237493
Recruitment Status : Completed
First Posted : January 23, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Ayman A. Zayed, MD, University of Jordan

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 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) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 687 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : July 24, 2017
Actual Study Completion Date : July 24, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low-dosage therapy 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])

Active Comparator: Regular-dosage therapy 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])




Primary Outcome Measures :
  1. Hypoglycemia [ Time Frame: 29 days of Ramadan ]
    Incidence of hypoglycemia

  2. Hyperglycemia [ Time Frame: 29 days of Ramadan ]
    Incidence of hyperglycemia


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237493


Locations
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Jordan
Jordan University Hospital
Amman, Amman Governorate, Jordan, 11942
Sponsors and Collaborators
University of Jordan
Investigators
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Principal Investigator: Ayman A. Zayed, MD The University of Jordan School of Medicine
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Responsible Party: Ayman A. Zayed, MD, Professor of Medicine, University of Jordan
ClinicalTrials.gov Identifier: NCT04237493    
Other Study ID Numbers: 671201612222
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ayman A. Zayed, MD, University of Jordan:
Diabetes Mellitus, Type 2
Fasting
Hypoglycemic Agents
Hypoglycemia
Hyperglycemia
Diabetic Ketoacidosis
Hyperglycemic Hyperosmolar Nonketotic Coma
Metformin
Glimepiride
Vildagliptin
Insulin Glargine
Insulin, Regular, Human
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Insulin Glargine
Glimepiride
Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action