Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-06 @ 9:38 PM
Study NCT ID:
NCT01960205
Status:
UNKNOWN
Last Update Posted:
2014-09-25
First Post:
2013-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D009765', 'term': 'Obesity'}], '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': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502994', 'term': 'saxagliptin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-23', 'studyFirstSubmitDate': '2013-10-07', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oral glucose tolerance test', 'timeFrame': 'Change of Blood sugar from baseline at 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Saxagliptin, prediabetes, glucose intolerance,obesity'], 'conditions': ['Prediabetes']}, 'referencesModule': {'references': [{'pmid': '28575729', 'type': 'DERIVED', 'citation': 'Wang Z, Xu D, Huang L, Zhang T, Wang J, Chen Q, Kong L, Zhou X. Effects of saxagliptin on glucose homeostasis and body composition of obese patients with newly diagnosed pre-diabetes. Diabetes Res Clin Pract. 2017 Aug;130:77-85. doi: 10.1016/j.diabres.2017.05.012. Epub 2017 May 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the effect of Saxagliptin in the newly diagnosed people with pre-diabetes and obesity besides lifestyle intervention ,there to evaluate DPP 4 inhibitors of reversing pre-diabetes curative effect to normal blood sugar, and observe its influences on the targets of obesity related metabolic abnormalities, to explore new ways for intervention on populations with pre-diabetes and obesity .', 'detailedDescription': 'Materials and Methods: This is a perspectiveness ,randomized, opening study, patients will be randomly assigned to the standarddose Saxagliptin group ,the lifestyle intervention group,the Metformin group and the low dose Saxagliptin group with a 6-month treatment period.\n\nOral glucose tolerance test will examined before and 6 months post-treatment during the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.Newly diagnosed insulin resistance or glucose intolerance .\n\n2.20 to 70 years of age.\n\n3.BMI≥28kg/m2，or BMI\\>25kg/m2 beside waistline≥80cm（female)，≥90cm(male).\n\nExclusion Criteria:\n\n1. Under Diabetes Mellitus treatment.\n2. Allergy to dipeptidyl peptidase 4 (DPP-4) inhibitors .\n3. Active heart failure.\n4. Unwilling or unable to sign inform consents.'}, 'identificationModule': {'nctId': 'NCT01960205', 'briefTitle': 'Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Shandong Provincial Hospital'}, 'officialTitle': 'Effect of Saxagliptin on Body Fat , Glucose and Beta Cell Function in Patients With Newly Diagnosed Pre-Diabetes Mellitus and Obesity', 'orgStudyIdInfo': {'id': 'ZXL-201308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standarddose Saxagliptin', 'description': 'Saxagliptin 5 mg (tablet) ,5mg a day and lifestyle intervention for 6 months', 'interventionNames': ['Drug: Saxagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lifestyle intervention', 'description': 'Lifestyle intervention for 6 months', 'interventionNames': ['Other: lifestyle intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'Metformin 500 mg (tablet) ,500mg three times a day and lifestyle intervention for 6 months', 'interventionNames': ['Drug: metformin']}, {'type': 'EXPERIMENTAL', 'label': 'low dose Saxagliptin', 'description': 'Saxagliptin 5 mg (tablet) ,2.5 mg a day and lifestyle intervention for 6 months', 'interventionNames': ['Drug: saxagliptin']}], 'interventions': [{'name': 'Saxagliptin', 'type': 'DRUG', 'otherNames': ['Onglyza'], 'description': '5mg a day for 6 months', 'armGroupLabels': ['Standarddose Saxagliptin']}, {'name': 'saxagliptin', 'type': 'DRUG', 'otherNames': ['Onglyza'], 'description': '2.5 mg a day for 6 months', 'armGroupLabels': ['low dose Saxagliptin']}, {'name': 'metformin', 'type': 'DRUG', 'otherNames': ['melbine'], 'description': '500mg three times a day for 6 months', 'armGroupLabels': ['Metformin']}, {'name': 'lifestyle intervention', 'type': 'OTHER', 'otherNames': ['living way intervention'], 'description': 'lifestyle intervention for 6 months', 'armGroupLabels': ['Lifestyle intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250021', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinli Zhou, MD, PhD', 'role': 'CONTACT', 'email': 'zhouxinli0301@163.com', 'phone': '15168889976'}, {'name': 'Xinli Zhou, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Xinli Zhou, MD,PhD', 'role': 'CONTACT', 'email': 'zhouxinli0301@163.com', 'phone': '15168889976'}], 'overallOfficials': [{'name': 'Xinli Zhou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Provincial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Chinese Medical Association', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Xinli Zhou', 'investigatorFullName': 'Xinli Zhou，MD，PHD', 'investigatorAffiliation': 'Shandong Provincial Hospital'}}}}