Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-02 @ 11:19 AM
Study NCT ID:
NCT01649466
Status:
COMPLETED
Last Update Posted:
2016-11-17
First Post:
2012-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients.
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': 'C475520', 'term': '1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine'}, {'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2012-07-20', 'studyFirstSubmitQcDate': '2012-07-24', 'lastUpdatePostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients reaching HbA1c below 7.0% without confirmed hypoglycemia and weight gain', 'timeFrame': '24 weeks', 'description': 'Primary endpoint is proportion of patients reaching the combined endpoint, defined as a blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events (BG measurement \\< 3.9mM (71mg/dL)) and weight gain.'}, {'measure': 'Rate of confirmed hypoglycemic events', 'timeFrame': '24 weeks', 'description': 'Co-primary endpoint is to evaluate the rate of confirmed hypoglycemic events (BG measurement \\< 3.9mM (71mg/dL)) in type 2 diabetes patients treated with vildagliptin versus NPH insulin add-on to glimepiride.'}], 'secondaryOutcomes': [{'measure': 'Incidence of severe hypoglycemic events', 'timeFrame': '24 weeks', 'description': 'To evaluate the incidence of severe hypoglycemic events (suspected grade 2 and confirmed grade 2 events) in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.'}, {'measure': 'Incidence of symptomatic hypoglycemic events', 'timeFrame': '24 weeks', 'description': 'To evaluate the incidence of symptomatic hypoglycemic events in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.'}, {'measure': 'Percentage of patients who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic event', 'timeFrame': '24 weeks', 'description': 'To evaluate the percentage of patients treated with vildagliptin versus NPH insulin add-on to glimepiride who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events.'}, {'measure': 'Change from baseline in body weight at 24 weeks', 'timeFrame': 'Baseline, 24 week', 'description': 'To evaluate body weight changes between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.'}, {'measure': 'Change from baseline in HbA1c at 24 weeks', 'timeFrame': 'Baseline, 24 week', 'description': 'To evaluate changes in HbA1c between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.'}, {'measure': 'Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) at 24 week', 'timeFrame': 'Baseline, 24 week', 'description': "The TSQM-9 is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication."}]}, 'conditionsModule': {'keywords': ['Type 2 diabetes mellitus, diabetes'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25867771', 'type': 'RESULT', 'citation': 'Forst T, Koch C, Dworak M. Vildagliptin versus insulin in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea: results from a randomized, 24 week study. Curr Med Res Opin. 2015 Jun;31(6):1079-84. doi: 10.1185/03007995.2015.1039936. Epub 2015 May 20.'}, {'pmid': '22295178', 'type': 'RESULT', 'citation': 'Zuckermann A, Wang SS, Ross H, Frigerio M, Eisen HJ, Bara C, Hoefer D, Cotrufo M, Dong G, Junge G, Keogh AM. Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial. J Transplant. 2011;2011:535983. doi: 10.1155/2011/535983. Epub 2011 Sep 13.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy to give treating physicians a guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is not sufficient to reach glycemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of type 2 diabetes mellitus.\n* Contraindicated or intolerant to take metformin.\n* HbA1c of ≥ 7.0% and ≤ 8.5%\n* Current sulfonylurea (glimepiride) monotherapy and judged by the investigator to be inadequately controlled\n* Other protocol-defined inclusion/exclusion criteria may apply\n\nExclusion Criteria:\n\n* Patients who are taking any other anti-diabetes drug (oral or injection) other than an SU component in the preceding 12 weeks.\n* Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state within the past 6 month\n* Patients taking sulfonylurea for longer than 5 years\n* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures\n* pregnancy\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01649466', 'acronym': 'BENEFIT', 'briefTitle': 'Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized Open-label Study to Compare Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Patients With Type 2 Diabetes Mellitus That do Not Reach Adequate Glycemic Control on Their Current Sulfonylurea Monotherapy.', 'orgStudyIdInfo': {'id': 'CLAF237ADE08'}, 'secondaryIdInfos': [{'id': '2012-001143-46', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vildagliptin', 'description': 'Patients randomized to the vildagliptin group will receive 50mg vildagliptin once daily add-on to their current glimepiride monotherapy for 24 weeks. No dose titrations are permitted during the study.', 'interventionNames': ['Drug: LAF237']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Protaphane', 'description': 'Patients randomized to the Protaphane group will receive a individualized dose of Protaphane once daily as bedtime dose. The Protaphane dose will be titrated within the first 4 weeks to reach fasting plasma glucose values below 100 mg/dl.', 'interventionNames': ['Drug: Protaphane']}], 'interventions': [{'name': 'LAF237', 'type': 'DRUG', 'description': 'Vildagliptin will be used as commercially available tablets of 50mg.', 'armGroupLabels': ['Vildagliptin']}, {'name': 'Protaphane', 'type': 'DRUG', 'description': 'Protaphane will be used as commercially available injection pens', 'armGroupLabels': ['Protaphane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38836', 'city': 'Anderbeck', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.98183, 'lon': 10.93356}}, {'zip': '86150', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '55545', 'city': 'Bad Kreuznach', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.8414, 'lon': 7.86713}}, 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