Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-27 @ 6:22 AM
Study NCT ID:
NCT04237493
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2020-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dosage Reduction and Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D016883', 'term': 'Diabetic Ketoacidosis'}, {'id': 'D006944', 'term': 'Hyperglycemic Hyperosmolar Nonketotic Coma'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007662', 'term': 'Ketosis'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003926', 'term': 'Diabetic Coma'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'C057619', 'term': 'glimepiride'}, {'id': 'D000077597', 'term': 'Vildagliptin'}, {'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 687}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-09', 'studyFirstSubmitDate': '2020-01-17', 'studyFirstSubmitQcDate': '2020-01-17', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoglycemia', 'timeFrame': '29 days of Ramadan', 'description': 'Incidence of hypoglycemia'}, {'measure': 'Hyperglycemia', 'timeFrame': '29 days of Ramadan', 'description': 'Incidence of hyperglycemia'}], 'secondaryOutcomes': [{'measure': 'Diabetic ketoacidosis', 'timeFrame': '29 days of Ramadan', 'description': 'Incidence of diabetic ketoacidosis'}, {'measure': 'Hyperosmolar hyperglycemic state', 'timeFrame': '29 days of Ramadan', 'description': 'Incidence of hyperosmolar hyperglycemic state'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 2', 'Fasting', 'Hypoglycemic Agents', 'Hypoglycemia', 'Hyperglycemia', 'Diabetic Ketoacidosis', 'Hyperglycemic Hyperosmolar Nonketotic Coma', 'Metformin', 'Glimepiride', 'Vildagliptin', 'Insulin Glargine', 'Insulin, Regular, Human'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '34305809', 'type': 'DERIVED', 'citation': 'Zaghlol LY, Beirat AF, Amarin JZ, Hassoun Al Najar AM, Hasan YY, Qtaishat A, Tierney ME, Zaghlol RY, Zayed AA. Effect of Dosage Reduction of Hypoglycemic Multidrug Regimens on the Incidences of Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan: A Randomized Controlled Trial. Front Endocrinol (Lausanne). 2021 Jul 7;12:613826. doi: 10.3389/fendo.2021.613826. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prospective participant is a returning patient with type 2 diabetes;\n* Prospective participant expressed an intention to fast during Ramadan;\n* Prospective participant has been compliant with one of four glucose-lowering multidrug regimens for at least the past three months.\n\nExclusion Criteria:\n\n* Prospective participant is a pregnant, postpartum, breastfeeding, or eumenorrheic woman;\n* Prospective participant has experienced diabetic ketoacidosis or hyperosmolar hyperglycemic state within three months;\n* Prospective participant has received niacin or corticosteroids within one month; and,\n* 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.'}, 'identificationModule': {'nctId': 'NCT04237493', 'briefTitle': 'Dosage Reduction and Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '671201612222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-dosage therapy', 'interventionNames': ['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)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regular-dosage therapy', 'interventionNames': ['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)']}], 'interventions': [{'name': 'Metformin and Glimepiride (Low Dosage)', 'type': 'DRUG', 'description': '* Metformin (PO; 850 mg; BID \\[with Ifṭār and with Suḥūr\\])\n* Glimepiride (PO; 1.5 or 3 mg \\[75% of the pre-Ramadan dose\\]; OD \\[with Ifṭār\\])', 'armGroupLabels': ['Low-dosage therapy']}, {'name': 'Metformin and Vildagliptin (Low Dosage)', 'type': 'DRUG', 'description': '* Metformin (PO; 850 mg; BID \\[with Ifṭār and with Suḥūr\\])\n* Vildagliptin (PO; 50 mg; OD \\[with Ifṭār\\])', 'armGroupLabels': ['Low-dosage therapy']}, {'name': 'Metformin and Insulin Glargine U100 (Low Dosage)', 'type': 'DRUG', 'description': '* Metformin (PO; 850 mg; BID \\[with Ifṭār and with Suḥūr\\])\n* Insulin Glargine U100 (SC; 9-33 units \\[75% of the pre-Ramadan dose\\]; OD \\[at 10 P.M.\\])', 'armGroupLabels': ['Low-dosage therapy']}, {'name': 'Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)', 'type': 'DRUG', 'description': '* Metformin (PO; 850 mg; BID \\[with Ifṭār and with Suḥūr\\])\n* Insulin Glargine U100 (SC; 6-39 units (75% of the pre-Ramadan dose); OD \\[at 10 P.M.\\])\n* Human Regular Insulin (SC; 15-33 units before Ifṭār and 6-18 units before Suḥūr \\[75% of the pre-Ramadan doses\\])', 'armGroupLabels': ['Low-dosage therapy']}, {'name': 'Metformin and Glimepiride (Regular Dosage)', 'type': 'DRUG', 'description': '* Metformin (PO; 850 mg; BID \\[with Ifṭār and with Suḥūr\\])\n* Glimepiride (PO; 2 or 4 mg \\[100% of the pre-Ramadan dose\\]; OD \\[with Ifṭār\\])', 'armGroupLabels': ['Regular-dosage therapy']}, {'name': 'Metformin and Vildagliptin (Regular Dosage)', 'type': 'DRUG', 'description': '* Metformin (PO; 850 mg; BID \\[with Ifṭār and with Suḥūr\\])\n* Vildagliptin (PO; 50 mg; BID \\[with Ifṭār and with Suḥūr\\]\\])', 'armGroupLabels': ['Regular-dosage therapy']}, {'name': 'Metformin and Insulin Glargine U100 (Regular Dosage)', 'type': 'DRUG', 'description': '* Metformin (PO; 850 mg; BID \\[with Ifṭār and with Suḥūr\\])\n* Insulin Glargine U100 (SC; 11-44 units \\[100% of the pre-Ramadan dose\\]; OD \\[at 10 P.M.\\])', 'armGroupLabels': ['Regular-dosage therapy']}, {'name': 'Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage)', 'type': 'DRUG', 'description': '* Metformin (PO; 850 mg; BID \\[with Ifṭār and with Suḥūr\\])\n* Insulin Glargine U100 (SC; 8-52 units (100% of the pre-Ramadan dose); OD \\[at 10 P.M.\\])\n* Human Regular Insulin (SC; 12-40 units before Ifṭār and 7-28 units before Suḥūr \\[100% of the pre-Ramadan doses\\])', 'armGroupLabels': ['Regular-dosage therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11942', 'city': 'Amman', 'state': 'Amman Governorate', 'country': 'Jordan', 'facility': 'Jordan University Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Ayman A. Zayed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Jordan School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jordan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Ayman A. Zayed, MD', 'investigatorAffiliation': 'University of Jordan'}}}}