Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT01414556
Status:
COMPLETED
Last Update Posted:
2013-04-02
First Post:
2011-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054795', 'term': 'Incretins'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-31', 'studyFirstSubmitDate': '2011-08-05', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glucagon/insulin(c-peptide) absolute, incremental and area under curve values', 'timeFrame': 'approx. 15 minutes intervals, time 0 to 120 min'}], 'secondaryOutcomes': [{'measure': 'plasma gut hormones and nutrients', 'timeFrame': 'approx. 15 minutes intervals, time 0 to 120 min'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '31665480', 'type': 'DERIVED', 'citation': 'Veedfald S, Vedtofte L, Skov-Jeppesen K, Deacon CF, Hartmann B, Vilsboll T, Knop FK, Christensen MB, Holst JJ. Glucose-Dependent Insulinotropic Polypeptide Is a Pancreatic Polypeptide Secretagogue in Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz097. doi: 10.1210/clinem/dgz097.'}, {'pmid': '24423311', 'type': 'DERIVED', 'citation': 'Christensen MB, Calanna S, Holst JJ, Vilsboll T, Knop FK. Glucose-dependent insulinotropic polypeptide: blood glucose stabilizing effects in patients with type 2 diabetes. J Clin Endocrinol Metab. 2014 Mar;99(3):E418-26. doi: 10.1210/jc.2013-3644. Epub 2013 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'Investigation of GIP effects at fasting and hypoglycemia'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasians 18 years or older with Type 2 diabetes (WHO criteria)\n\nExclusion Criteria:\n\n* HbA1c \\>9 %\n* Liver disease (ALAT/ASAT \\>2 x upper normal limit)\n* Diabetic nephropathy (s-creatinine \\>130 µM or albuminuria)\n* Proliferative diabetic retinopathy (anamnestic)\n* Severe arteriosclerosis or heart failure (NYHA group III og IV)\n* Anemia\n* treatment with medication not applicable to pause for 12 hours\n* Fasting plasma glucose \\>15 mM on screening day.'}, 'identificationModule': {'nctId': 'NCT01414556', 'acronym': 'GIP-HYPO-T2DM', 'briefTitle': 'GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Effects of Glucose-dependent Insulinotropic Polypeptide at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'H-2-2009-078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hyperglycemia', 'interventionNames': ['Other: Glucose-dependent Insulinotropic polypeptide', 'Other: saline']}, {'type': 'EXPERIMENTAL', 'label': 'fasting glycemia', 'interventionNames': ['Other: Glucose-dependent Insulinotropic polypeptide', 'Other: saline']}, {'type': 'EXPERIMENTAL', 'label': 'hypoglycemia', 'interventionNames': ['Other: Glucose-dependent Insulinotropic polypeptide', 'Other: saline']}], 'interventions': [{'name': 'Glucose-dependent Insulinotropic polypeptide', 'type': 'OTHER', 'description': 'infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min', 'armGroupLabels': ['fasting glycemia', 'hyperglycemia', 'hypoglycemia']}, {'name': 'saline', 'type': 'OTHER', 'armGroupLabels': ['fasting glycemia', 'hyperglycemia', 'hypoglycemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Gentofte Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mikkel Christensen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mikkel Christensen', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}