Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-03-13 @ 4:25 AM
Study NCT ID:
NCT02351232
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2015-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Lira Pump Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune 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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2015-01-27', 'studyFirstSubmitQcDate': '2015-01-29', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': '6 months', 'description': 'Change in HbA1c from baseline to end of study (time 6 months)'}], 'secondaryOutcomes': [{'measure': 'Change in weight', 'timeFrame': '6 months', 'description': 'Change in weight from baseline to end of study (time 6 months)'}, {'measure': 'Change in insulin pump settings', 'timeFrame': '6 months', 'description': 'Change in insulin pump settings from baseline to 3 weeks, 3 months and 6 months'}, {'measure': 'Change in glucose variability as measured by continuous glucose monitoring', 'timeFrame': '6 months', 'description': 'Change in glucose variability from baseline to 3 weeks, 3 months and 6 months'}, {'measure': 'Change in body composition as measured by DXA-scan', 'timeFrame': '6 months', 'description': 'Change in body composition from baseline to 6 months'}, {'measure': 'Change in blood pressure', 'timeFrame': '6 months', 'description': 'Change in blood pressure from baseline to 6 months'}, {'measure': 'Change in lipid profile (LDL, HDL, VLDL, total cholesterol, triglycerides)', 'timeFrame': '6 months', 'description': 'Change in lipid profile from baseline to 6 months'}, {'measure': 'Frequency of hypoglycemia (patient reported number of episodes with blood glucose <3.9 mmol/l)', 'timeFrame': '6 months', 'description': 'Frequency of hypoglycemia during the 6-month study period'}, {'measure': 'Change in kidney function as measured by urine albumine/creatinine ratio', 'timeFrame': '6 months', 'description': 'Change in kidney function from baseline to 6 months'}, {'measure': 'Number of daily blood glucose measurements', 'timeFrame': '6 months', 'description': 'Number of daily blood glucose measurements during the 6-month study period'}, {'measure': 'Change in diet as measured by retrospective food recording', 'timeFrame': '6 months', 'description': 'Change in dietary behavior from baseline to 3 and 6 months'}, {'measure': 'Change in treatment satisfaction as measured by Diabetes Treatment Satisfaction Questionnaire', 'timeFrame': '6 months', 'description': 'Change in treatment satisfaction from baseline to 3 and 6 months'}, {'measure': 'Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale', 'timeFrame': '6 months', 'description': 'Change in anxiety and depression from baseline to 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '31696598', 'type': 'RESULT', 'citation': 'Dejgaard TF, Schmidt S, Frandsen CS, Vistisen D, Madsbad S, Andersen HU, Norgaard K. Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin-pump-treated patients with type 1 diabetes: The Lira Pump trial-a randomized, double-blinded, placebo-controlled trial. Diabetes Obes Metab. 2020 Apr;22(4):492-500. doi: 10.1111/dom.13911. Epub 2019 Dec 19.'}]}, 'descriptionModule': {'briefSummary': 'A randomized placebo-controlled clinical trial investigating the effects of Liraglutide as an add-on to intensive insulin therapy in overweight insulin pump treated type 1 diabetes patients in suboptimal glycemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 1 diabetes ≥ 1 year\n* BMI \\> 25 kg/m2\n* Insulin pump ≥ 1 year\n* HbA1c \\> 58 mmol/mol\n* Use of carbohydrate counting and the insulin pump bolus calculator\n\nExclusion Criteria:\n\n* Gastroparesis\n* Impaired renal function (eGFR \\< 60 ml/min/1.73m2)\n* Liver disease with ALAT \\> 2.5 times the upper limit of the reference interval\n* Acute or chronic pancreatitis or history of chronic pancreatitis or idiopathic acute pancreatitis\n* Inflammatory bowel disease\n* History of cancer (except basal cell skin cancer) which in the investigators opinion could interfere with the results of the trial, or cancer during the past 5 years\n* Thyroid adenoma\n* Subjects with personal or family history of MTC or MEN2\n* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start\n* Known or suspected alcohol or drug abuse\n* Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation\n* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.\n* Simultaneous participation in any other clinical intervention trial\n* Known or suspected hypersensitivity to Liraglutide\n* Inability to understand the patient information and to give informed consent\n* Acute treatment required proliferative retinopathy or maculopathy (macular oedema)\n* Any Cardiac disorder which in the investigators opinion could interfere with the safety and results of the trial."}, 'identificationModule': {'nctId': 'NCT02351232', 'briefTitle': 'The Lira Pump Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'The Lira Pump Trial. The Effects of Liraglutide in Patients With Insulin Pump Treated Type 1 Diabetes: A Randomized Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': 'LPT2015'}, 'secondaryIdInfos': [{'id': '2014-002285-76', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Liraglutide; daily subcutaneous injection; 1.8 mg; 6 months', 'interventionNames': ['Drug: Liraglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo; daily subcutaneous injection; 1.8 mg; 6 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['Victoza'], 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Gentofte Municipality', 'country': 'Denmark', 'facility': 'Steno Diabetes Center', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}, {'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Kirsten Nørgaard, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Signe Schmidt', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}