Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-04 @ 3:22 PM
Study NCT ID:
NCT03320694
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2017-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D007328', 'term': 'Insulin'}, {'id': 'D000068880', 'term': 'Isophane Insulin, Human'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}, {'id': 'D007336', 'term': 'Insulin, Isophane'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061386', 'term': 'Insulin, Regular, Human'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-25', 'studyFirstSubmitDate': '2017-09-30', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maternal glycemic control', 'timeFrame': 'From time of randomisation till 40 weeks', 'description': 'Maternal glycemic control was measured by blood sugar levels'}], 'secondaryOutcomes': [{'measure': 'Fetal macrosomia', 'timeFrame': 'at birth', 'description': 'Birth weight more than 4kg'}, {'measure': 'Apgar score', 'timeFrame': 'at birth', 'description': '\\<7 at 5min'}, {'measure': 'Neonatal intensive care unit (NICU) stay', 'timeFrame': '>24 hours after birth', 'description': 'Admitted to NICU'}, {'measure': 'Perinatal death', 'timeFrame': '7 days of delivery', 'description': 'Fetal or neonatal death within 7 days'}, {'measure': 'mode of delivery', 'timeFrame': 'at delivery', 'description': 'Lower segment cesarean section , Spontaneous Vaginal Delivery, Instrumental delivery'}, {'measure': 'Neonatal hypoglycemia', 'timeFrame': 'at birth', 'description': 'Neonatal blood sugar was checked at birth and if \\<2.2mmol/l, was labelled'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gestational Diabetes Mellitus, Metformin, Insulin'], 'conditions': ['Gestational Diabetes Mellitus in Pregnancy']}, 'descriptionModule': {'briefSummary': 'Gestational diabetic mellitus (GDM) patients randomised to metformin or insulin group.Aim was to achieve blood sugar levels of Blood sugar fasting (BSF) \\<5.3 mmol/l and 1 hour post meal\\<7.8mmol/l. Both groups were followed till delivery and outcome studied.', 'detailedDescription': '75 gm Oral Glucose Tolerance Test (OGTT) was done in pregnant patients. Blood sugar fasting(BSF) \\> 5.5 mmol/l \\& 2 hours postprandial \\>7.8 mmol/l was labelled as GDM. They were randomised to metformin or insulin group. Those assigned to metformin group were started metformin 500mg twice daily \\& increased until 2500mg depending on the blood sugar levels. Aim was to achieve blood sugar levels of BSF \\<5.3 mmol/l and 1 hour post meal\\<7.8mmol/l. If blood sugar levels were not controlled, insulin was added. The insulin group was given 3 injections of regular insulin \\& one intermediate acting insulin injection at night subcutaneously. Both groups were followed till delivery and outcome studied'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:•\n\n* All pregnant Diagnosed GDM in pregnancy by OGTT from 22 week to 34 week with singleton pregnancy\n\nExclusion Criteria:\n\n* Patients with Known diabetes mellitus\n* Patients with multiple pregnancy\n* With essential hypertension or pre eclampsia\n* Patients having fetal malformation incompatible with life\n* Patients with intrauterine death of fetus'}, 'identificationModule': {'nctId': 'NCT03320694', 'briefTitle': 'Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Services Institute of Medical Sciences, Pakistan'}, 'officialTitle': 'Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'IRB/2015/211/SIMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'metformin', 'description': 'Metformin will be given until 2500mg in divided doses till normoglycemia is achieved and will be continued till delivery', 'interventionNames': ['Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin', 'description': 'Insulin will be give as 3 regular injection and one intermediate acting injection at bedtime till normoglycemia is achieved and will be continued till delivery', 'interventionNames': ['Drug: Insulin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'metformin 500mg twice daily \\& increased until 2500mg till normoglycemia was achieved and was continued till delivery', 'armGroupLabels': ['metformin']}, {'name': 'Insulin', 'type': 'DRUG', 'otherNames': ['Humulin R U 100 and Humulin N'], 'description': 'The insulin group was given 3 S/C injections of regular insulin \\& one intermediate acting injection at night till normoglycemia was achieved and was continued till delivery', 'armGroupLabels': ['Insulin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Services Institute of Medical Sciences', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Services Institute of Medical Sciences, Pakistan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Obs Gynae', 'investigatorFullName': 'Tayyiba Wasim', 'investigatorAffiliation': 'Services Institute of Medical Sciences, Pakistan'}}}}