Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-26 @ 12:12 PM
Study NCT ID:
NCT01511692
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2012-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}, {'id': 'C057619', 'term': 'glimepiride'}], '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-24', 'studyFirstSubmitDate': '2012-01-12', 'studyFirstSubmitQcDate': '2012-01-18', 'lastUpdatePostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10'}], 'secondaryOutcomes': [{'measure': 'The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10'}, {'measure': 'Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10'}, {'measure': 'Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10'}, {'measure': 'Total duration of eating at the buffet meal (satiation)'}, {'measure': 'Weight'}, {'measure': 'Waist circumference'}, {'measure': 'Adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '22446097', 'type': 'RESULT', 'citation': 'Horowitz M, Flint A, Jones KL, Hindsberger C, Rasmussen MF, Kapitza C, Doran S, Jax T, Zdravkovic M, Chapman IM. Effect of the once-daily human GLP-1 analogue liraglutide on appetite, energy intake, energy expenditure and gastric emptying in type 2 diabetes. Diabetes Res Clin Pract. 2012 Aug;97(2):258-66. doi: 10.1016/j.diabres.2012.02.016. Epub 2012 Mar 24.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effects of liraglutide on energy intake in subjects with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 diabetes mellitus\n* Diet-treated subjects and/or subjects with type 2 diabetes in OAD (oral anti-diabetic drug) mono-therapy\n* HbA1c for diet-treated subjects: HbA1c between 6.5-10.0% (both inclusive) and for OAD treated subjects: HbA1c between 6.5-9.5% (both inclusive)\n* Body mass index (BMI) between 27-40 kg/m\\^2 (both inclusive)\n* Subjects should have a stable body weight for at least 3 months prior to screening (as documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight)\n* Euthyroid subjects\n* Subjects should be unrestrained eaters\n\nExclusion Criteria:\n\n* Recurrent severe hypoglycaemia\n* Impaired liver function\n* Impaired renal function\n* Cardiac problems\n* Uncontrolled treated/untreated hypertension\n* Known or suspected allergy to trial products or related products\n* Use of any drug (except for OADs), which in the investigator's opinion could interfere with the subject's glucose level or body weight\n* Active hepatitis B and/or active hepatitis C\n* Positive HIV (human immunodeficiency virus) antibodies\n* Known or suspected abuse of alcohol or narcotics\n* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, cola drinks, chocolate) as judged by the Investigator"}, 'identificationModule': {'nctId': 'NCT01511692', 'briefTitle': 'Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A 4 Week Single Center, Double-dummy, Randomised Double-blind, Balanced Incomplete Latin Square Design Study to Evaluate the Effects of Liraglutide on Appetite in Subjects With Type 2 Diabetes Compared to Glimepiride and Placebo', 'orgStudyIdInfo': {'id': 'NN2211-1589'}, 'secondaryIdInfos': [{'id': '2006-000377-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lira --> placebo', 'interventionNames': ['Drug: liraglutide', 'Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo --> glim', 'interventionNames': ['Drug: placebo', 'Drug: glimepiride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glim --> lira', 'interventionNames': ['Drug: liraglutide', 'Drug: glimepiride']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': '1.8 mg/day injected subcutaneously for 4 weeks', 'armGroupLabels': ['Glim --> lira', 'Lira --> placebo']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Liraglutide placebo, injected subcutaneously for 4 weeks', 'armGroupLabels': ['Lira --> placebo']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks', 'armGroupLabels': ['Placebo --> glim']}, {'name': 'glimepiride', 'type': 'DRUG', 'description': 'Dose individually adjusted, administered orally for 4 weeks', 'armGroupLabels': ['Glim --> lira', 'Placebo --> glim']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5005', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}