Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT02315495
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2014-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
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': 'C502994', 'term': 'saxagliptin'}, {'id': 'D020909', 'term': 'Acarbose'}], 'ancestors': [{'id': 'D014312', 'term': 'Trisaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-04', 'studyFirstSubmitDate': '2014-12-03', 'studyFirstSubmitQcDate': '2014-12-08', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose concentrations at pre-defined intervals', 'timeFrame': '-60,-10,0,30,60,90,120,180min'}], 'secondaryOutcomes': [{'measure': 'Plasma concentrations of incretin hormones at pre-defined intervals', 'timeFrame': '-60,-10,0,30,60,90,120,180min'}, {'measure': 'Plasma concentrations of insulin at pre-defined intervals', 'timeFrame': '-60,-10,0,30,60,90,120,180min'}, {'measure': 'Plasma concentrations of C-peptide at pre-defined intervals', 'timeFrame': '-60,-10,0,30,60,90,120,180min'}, {'measure': 'Plasma concentrations of glucagon at pre-defined intervals', 'timeFrame': '-60,-10,0,30,60,90,120,180min'}, {'measure': 'half-emptying time (T50)', 'timeFrame': '0-180min'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The proposed study is designed to evaluate (i) the effects of saxagliptin, with or without acarbose, on gastric emptying, postprandial glycaemia, and plasma intact GLP-1, insulin, C-peptide and glucagon after a high carbohydrate meal, and (ii) whether the magnitude of the effects of saxagliptin and/or acarbose is related to the rate of gastric emptying, in patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin)\n* Body mass index (BMI) 20 - 40 kg/m2\n* Age 18 - 70 years\n* Males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)\n* Glycated haemoglobin A1c (HbA1c) ≥ 6.0% and ≤ 7.9%\n* Haemoglobin above the lower limit of the normal range (i.e. \\>135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (i.e. \\>10mcg/L)\n\nExclusion Criteria:\n\n* Use of any medication that may influence gastrointestinal motor function, body weight or appetite\n* Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis\n* History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)\n* Other significant illness, including epilepsy, cardiovascular or respiratory disease\n* Autonomic nerve damage (as assessed by standardised cardiovascular reflex tests \\[36\\])\n* Impaired renal or liver function (as assessed by calculated creatinine clearance \\< 90 mL/min or abnormal liver function tests (\\> 2 times upper limit of normal range))\n* Allergy to vildagliptin or any other 'gliptin'\n* Donation of blood within the previous 3 months\n* Participation in any other research studies within the previous 3 months\n* Females who are pre-menopausal\n* Inability to give informed consent\n* Vegetarians"}, 'identificationModule': {'nctId': 'NCT02315495', 'briefTitle': 'Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'ISSSAXA0015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5 mg saxagliptin + 100 mg acarbose', 'description': 'Acute dosing:\n\n5 mg saxagliptin is given with water, 60 min before a test meal 100 mg acarbose is given with a test meal', 'interventionNames': ['Drug: Saxagliptin', 'Drug: Acarbose']}, {'type': 'EXPERIMENTAL', 'label': '5 mg saxagliptin', 'description': 'Acute dosing:\n\n5 mg saxagliptin is given 60 min before a test meal,', 'interventionNames': ['Drug: Saxagliptin']}, {'type': 'EXPERIMENTAL', 'label': '100 mg acarbose', 'description': 'Acute dosing:\n\n100 mg acarbose is given with a test meal', 'interventionNames': ['Drug: Acarbose']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'Saxagliptin', 'type': 'DRUG', 'otherNames': ['Onglyza'], 'armGroupLabels': ['5 mg saxagliptin', '5 mg saxagliptin + 100 mg acarbose']}, {'name': 'Acarbose', 'type': 'DRUG', 'otherNames': ['Glucobay'], 'armGroupLabels': ['100 mg acarbose', '5 mg saxagliptin + 100 mg acarbose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zilin Sun', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD of Department of Endocrinology', 'investigatorFullName': 'Zilin Sun', 'investigatorAffiliation': 'Zhongda Hospital'}}}}