Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-01 @ 10:49 PM
Study NCT ID:
NCT03702660
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2017-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of GIP After a Meal in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619446', 'term': 'gastric inhibitory polypeptide (3-30)-amide'}, {'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}], 'ancestors': [{'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-23', 'studyFirstSubmitDate': '2017-10-30', 'studyFirstSubmitQcDate': '2018-10-10', 'lastUpdatePostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucagon', 'timeFrame': '8 weeks - 6 months', 'description': 'Plasma levels of glucagon after a meal in patients with type 2-diabetes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of antagonising GIP after a meal on plasma levels of glucagon. 10 participants are going through four experimental days each, where they ingest a meal and afterwards receive infusions of either GIP receptor antagonist, GLP-1, GIP receptor antagonist + GLP-1 or placebo (saline) in a randomised order. The primary endpoint of the study is plasma levels of glucagon, which we hypothesize will decrease with infusion of GIP receptor antagonist and/or with infusion of GLP-1.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasians between 18-75 years with diet og Metformin treated type 2-diabetes\n* HbA1c \\< 75 mmol/mol\n* BMI \\> 27 kg/m2\n* Stable weight (+/- 5%) during the last 3 months\n\nExclusion Criteria:\n\n* Treatment with medicine or dietary supplements that cannot the paused for 12 hours\n* More than 14 units of alcohol weekly or abuse of drugs\n* Liver disease, estimated at plasma ALAT levels \\> 3 x normal value or INR outside normal range\n* Reduced kidney function (estimated at eGFR \\< 60 ml/min/1,73 m2)\n* Severe arteriosclerotic heart disease or heart failure (NYHA III or IV)\n* Low red blood cell count (hemoglobin \\< 8.3 mmol/l\n* Special diet or planned weight change during the trial period\n* Any disease/condition, which the clinical investigators assess will disturb the participation in the clinical trial'}, 'identificationModule': {'nctId': 'NCT03702660', 'acronym': 'GA-7', 'briefTitle': 'Effect of GIP After a Meal in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Effect of GIP-receptorantantagonist on Glucagon Plasma Levels After a Meal in Patients With Type 2-diabetes', 'orgStudyIdInfo': {'id': 'GA-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GIP(3-30)NH2', 'description': 'GIP receptor antagonist', 'interventionNames': ['Other: GIP(3-30)NH2', 'Other: Peripheral venous cannulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (saline infusions)', 'interventionNames': ['Other: Peripheral venous cannulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GLP-1', 'interventionNames': ['Other: Peripheral venous cannulation', 'Other: GLP-1']}, {'type': 'EXPERIMENTAL', 'label': 'GLP-1 + GIP(3-30)NH2', 'interventionNames': ['Other: GIP(3-30)NH2', 'Other: Peripheral venous cannulation', 'Other: GLP-1']}], 'interventions': [{'name': 'GIP(3-30)NH2', 'type': 'OTHER', 'description': 'Peptide derived from the naturally occuring gut hormone GIP', 'armGroupLabels': ['GIP(3-30)NH2', 'GLP-1 + GIP(3-30)NH2']}, {'name': 'Peripheral venous cannulation', 'type': 'OTHER', 'description': 'Intravenous access for infusions', 'armGroupLabels': ['GIP(3-30)NH2', 'GLP-1', 'GLP-1 + GIP(3-30)NH2', 'Placebo']}, {'name': 'GLP-1', 'type': 'OTHER', 'description': 'Peptide infusion', 'armGroupLabels': ['GLP-1', 'GLP-1 + GIP(3-30)NH2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Center for Diabetes Research, Gentofte Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Signe Stensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Diabetes Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Signe Stensen', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}