Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT00993720
Status:
COMPLETED
Last Update Posted:
2011-01-21
First Post:
2009-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-20', 'studyFirstSubmitDate': '2009-10-09', 'studyFirstSubmitQcDate': '2009-10-09', 'lastUpdatePostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insulin-dose', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': '24-hours glucose profiles with and without treatment of Victoza', 'timeFrame': 'three days'}, {'measure': 'risk of hypoglycemia during physical activity with and without Victoza', 'timeFrame': 'one day'}, {'measure': 'gastric emptying rate during hypoglycemia with and without Victoza', 'timeFrame': 'one day'}, {'measure': 'weight change from baseline, change in fructosamine from baseline', 'timeFrame': 'four weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['patients with type 1 diabetes mellitus'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '21593296', 'type': 'DERIVED', 'citation': 'Kielgast U, Krarup T, Holst JJ, Madsbad S. Four weeks of treatment with liraglutide reduces insulin dose without loss of glycemic control in type 1 diabetic patients with and without residual beta-cell function. Diabetes Care. 2011 Jul;34(7):1463-8. doi: 10.2337/dc11-0096. Epub 2011 May 18.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-50y,\n* BMI 18-27,\n* caucasian origin,\n* type 1 diabetes diagnosed between age 5 and age 40,\n* no known diabetes complications or cardiovascular diseases,\n* no medication known to influence glucose homeostasis,\n* no pregnancy\n\nExclusion Criteria:\n\n* diabetes complications,\n* autonomous nerve dysfunction,\n* anaemia,\n* HbA1c \\< 8.5% at screening,\n* estimated by the investigator to be incapable of completing the trial.'}, 'identificationModule': {'nctId': 'NCT00993720', 'briefTitle': 'Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '2009-001930-80'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'type 1 DM with betacell function: Liraglutide', 'interventionNames': ['Drug: Liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'type 1 DM without betacell function: Liraglutide', 'interventionNames': ['Drug: Liraglutide']}, {'type': 'NO_INTERVENTION', 'label': 'type 1 DM without betacell function: Insulin', 'interventionNames': ['Other: continuous insulin therapy']}], 'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'description': 'after optimal treatment on insulin alone 10 patients with type 1 diabetes are treated for four weeks with Liraglutide : in the first week at 0.6 mg sc and after one week optitration to the recommended 1.2 mg sc pr day.', 'armGroupLabels': ['type 1 DM with betacell function: Liraglutide']}, {'name': 'Liraglutide', 'type': 'DRUG', 'description': 'after optimal treatment with insulin alone, 10 type 1 diabetic patients are treated with Liraglutide at a dose of 0.6 mg sc. After one week the dose is optitreted to the recommended 1.2 mg sc pr. day.', 'armGroupLabels': ['type 1 DM without betacell function: Liraglutide']}, {'name': 'continuous insulin therapy', 'type': 'OTHER', 'description': 'after optimal treatment with insulin, patients continue on insulin for four weeks', 'armGroupLabels': ['type 1 DM without betacell function: Insulin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sten Madsbad, MD, chief physician', 'oldOrganization': 'Hvidovre University Hospital'}}}}