Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-06 @ 2:15 AM
Study NCT ID:
NCT03246451
Status:
COMPLETED
Last Update Posted:
2018-07-09
First Post:
2017-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of GLP-1 Receptor Signalling in the Glucose-lowering Effect of Metformin in Patients With T2D
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'C083773', 'term': 'exendin (9-39)'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-06', 'studyFirstSubmitDate': '2017-08-01', 'studyFirstSubmitQcDate': '2017-08-07', 'lastUpdatePostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma glucose', 'timeFrame': 'Minutes 240', 'description': 'The difference between the effect of metformin on postprandial glucose tolerance (as assessed by area under curve (AUC) for plasma glucose during a standardised liquid mixed meal test) with and without blockade of GLP-1 signalling by exendin 9-39.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GLP-1', 'glucagon-like peptide-1', 'Metformin', 'Exendin(9-39)'], 'conditions': ['Glucose Metabolism Disorders']}, 'referencesModule': {'references': [{'pmid': '39049802', 'type': 'DERIVED', 'citation': 'Hansen LS, Gasbjerg LS, Bronden A, Dalsgaard NB, Bahne E, Stensen S, Hellmann PH, Rehfeld JF, Hartmann B, Wewer Albrechtsen NJ, Holst JJ, Vilsboll T, Knop FK. The role of glucagon-like peptide 1 in the postprandial effects of metformin in type 2 diabetes: a randomized crossover trial. Eur J Endocrinol. 2024 Aug 5;191(2):192-203. doi: 10.1093/ejendo/lvae095.'}]}, 'descriptionModule': {'briefSummary': 'Delineation of the role of glucagon-like peptide-1 receptor signalling in the glucose-lowering effect of metformin during meal ingestion in patients with type 2 diabetes.', 'detailedDescription': 'Aim: To evaluate the contribution of metformin-induced GLP-1 secretion on the glucose-lowering effect of metformin in patients with type 2 diabetes treated with metformin for 14 days. Furthermore, the investigators aim to elucidate the mechanisms by which metformin-induced GLP-1 secretion may affect glucose levels in patients with type 2 diabetes.\n\nFifteen patients with type 2 diabetes treated with lifestyle intervention and/or metformin as the only glucose-lowering drug will be enrolled in the study. The effect of a 14-day metformin treatment course on postprandial glucose tolerance will be examined with and without infusion of the GLP-1 receptor antagonist exendin9-39 in 15 patients with type 2 diabetes.\n\nThe double-blinded, placebo-controlled, randomised, cross-over study consists of four study days with concomitant infusions of A) placebo + placebo, B) placebo + exendin9-39, C) metformin + placebo and D) metformin + exendin9-39.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes for at least three months (diagnosed according to the criteria of the World Health Organization (WHO)), with a HbA1c \\<58 mmol/mol.\n* Caucasian ethnicity\n* Lifestyle intervention and/or metformin monotherapy\n* Normal haemoglobin\n* Age \\>18 years\n* BMI \\>23 kg/m2 and \\<35 kg/m2\n* Informed and written consent\n\nExclusion Criteria:\n\n* Liver disease\n* Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery\n* Hypo- or hyperphosphataemia\n* Reduced kidney function or nephropathy\n* Treatment with medicine that cannot be paused for 12 hours\n* Intake of antibiotics two months prior to study\n* Hypo- or hypercalcaemia\n* Hypo- and hyperthyroidism\n* Treatment with oral anticoagulants\n* Active or recent malignant disease\n* Any treatment or condition requiring acute or sub-acute medical or surgical intervention\n* Lack of effective birth control in premenopausal women\n* Positive pregnancy test on study days in premenopausal women\n* Pregnancy\n* Women who are breastfeeding\n* Any condition considered incompatible with participation by the investigators\n* If the subjects receive any antibiotic treatment while included in the study they will be excluded'}, 'identificationModule': {'nctId': 'NCT03246451', 'briefTitle': 'The Role of GLP-1 Receptor Signalling in the Glucose-lowering Effect of Metformin in Patients With T2D', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'The Role of GLP-1 Receptor Signalling in the Glucose-lowering Effect of Metformin During Meal Ingestion in Patients With T2D', 'orgStudyIdInfo': {'id': 'UHG-CFD-METEX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, oral tablet in 14 days and in liquid meal.', 'interventionNames': ['Drug: Placebo Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': 'Metformin, oral tablet 2-4 x 500 mg in 14 days and in liquid meal.', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Saline', 'description': 'Saline infusion (9mg/mL) on experimental days', 'interventionNames': ['Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Exendin(9-39)', 'description': 'Exendin(9-39) infusion. GLP-1 receptor antagonist used as a study tool on experimental days.', 'interventionNames': ['Drug: Exendin (9-39)']}], 'interventions': [{'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': '2-4 tablets in 14 days', 'armGroupLabels': ['Placebo']}, {'name': 'Metformin', 'type': 'DRUG', 'description': '1000-2000 mg in 14 days', 'armGroupLabels': ['Metformin']}, {'name': 'Saline', 'type': 'DRUG', 'description': '9 mg/ml saline infusion during experimental days', 'armGroupLabels': ['Saline']}, {'name': 'Exendin (9-39)', 'type': 'DRUG', 'description': 'Infusion of GLP-1 receptor antagonist used as a tool during experimental days', 'armGroupLabels': ['Exendin(9-39)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Gentofte Municipality', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Center for Diabetes Research', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}], 'overallOfficials': [{'name': 'Filip K Knop, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UHGentofte, Center for Diabetes Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Bachelor of Science', 'investigatorFullName': 'Laura Smidt Hansen', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}