Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2025-12-27 @ 12:49 PM
Study NCT ID:
NCT00969566
Status:
COMPLETED
Last Update Posted:
2012-01-06
First Post:
2009-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Parameters for Efficacy of Sitagliptin and Metformin Combination
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': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-05', 'studyFirstSubmitDate': '2009-08-31', 'studyFirstSubmitQcDate': '2009-08-31', 'lastUpdatePostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of HbA1c', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Fasting Plasma Glucose (FPG)', 'timeFrame': '52 weeks'}, {'measure': 'Postprandial Plasma Glucose (PPG)', 'timeFrame': '52 weeks'}, {'measure': 'C-peptide', 'timeFrame': '52 weeks'}, {'measure': 'Glucagon', 'timeFrame': '52 weeks'}, {'measure': 'Homeostatic model assessment of insulin resistance (HOMA-IR)', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Sitagliptin', 'C-peptide', 'Glucagon'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels in both fasting and postprandial states and preserves pancreatic beta cell function in patients with type 2 diabetes. Their mechanism of action is derived from increased incretin (GLP-1) levels, which stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas. Recent studies reported that combination therapy with DPP-IV inhibitors and metformin have additive or synergistic effects in lowering glycose level, preserving beta-cell mass and function as well as enhancing insulin sensitivity. However, there have been few studies about the difference of glucose lowering effect of combination therapy of DPP-IV inhibitors and metformin according to the secretory capacity of pancreas.\n\nThe researchers hypothesized that combination therapy with DPP-IV inhibitor and metformin may have more favorable glucose lowering effect in type 2 diabetic patients who have preserved pancreatic secretory function. The researchers plan to investigate the difference of glucose lowering effect of 24 weeks treatment with sitagliptin (DPP-IV inhibitor) in combination with metformin according to basal c-peptide and glucagon level in type 2 diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* HbA1c ≥ 7%\n* Age ≥ 18\n\nExclusion Criteria:\n\n* Contraindication to sitagliptin or metformin\n* Pregnant or breast feeding women\n* Reproductive-age women who refuse contraception\n* Type 1 diabetes, gestational diabetes, or diabetes with secondary cause\n* Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \\> 3-fold the upper limit of normal)\n* Renal failure (Cr \\> 2.0)\n* Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment)\n* Not appropriate for oral antidiabetic agent\n* Medication which affect glycemic control\n* Disease which affect efficacy and safety of drugs\n* Other clinical trial within 30 days'}, 'identificationModule': {'nctId': 'NCT00969566', 'acronym': 'COSMETIC', 'briefTitle': 'Predictive Parameters for Efficacy of Sitagliptin and Metformin Combination', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Predictive Parameters for Therapeutic Efficacy of Initial Combination Therapy With Sitagliptin and Metformin in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'SNUBH_ENDO1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin+Sitagliptin', 'description': 'Initial combination of metformin and sitagliptin', 'interventionNames': ['Drug: sitagliptin, metformin']}], 'interventions': [{'name': 'sitagliptin, metformin', 'type': 'DRUG', 'otherNames': ['Januvia'], 'description': 'sitagliptin 100mg once daily and metformin 500mg twice daily, orally, for 24 weeks.', 'armGroupLabels': ['Metformin+Sitagliptin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Soo Lim, MD, MPH, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Soo Lim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}