Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT01441232
Status:
COMPLETED
Last Update Posted:
2012-01-31
First Post:
2011-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacodynamic Effects of Single-Dose Co-Administration of LX4211 With Januvia® in Type 2 Diabetics
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': 'C575681', 'term': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'lastUpdateSubmitDate': '2012-01-26', 'studyFirstSubmitDate': '2011-09-23', 'studyFirstSubmitQcDate': '2011-09-26', 'lastUpdatePostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in gut hormones', 'timeFrame': 'Days 1, 8, and 15'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in fasting plasma glucose', 'timeFrame': 'Days 1, 8, and 15'}, {'measure': 'Change from baseline in postprandial glucose', 'timeFrame': 'Days 1, 8, and 15'}, {'measure': 'Change from baseline in insulin', 'timeFrame': 'Days 1, 8, and 15'}, {'measure': 'Change from baseline in peptide YY', 'timeFrame': 'Days 1, 8, and 15'}, {'measure': 'Change from baseline in urinary glucose excretion', 'timeFrame': 'Days 1, 8, and 15'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23433601', 'type': 'DERIVED', 'citation': 'Zambrowicz B, Ding ZM, Ogbaa I, Frazier K, Banks P, Turnage A, Freiman J, Smith M, Ruff D, Sands A, Powell D. Effects of LX4211, a dual SGLT1/SGLT2 inhibitor, plus sitagliptin on postprandial active GLP-1 and glycemic control in type 2 diabetes. Clin Ther. 2013 Mar;35(3):273-285.e7. doi: 10.1016/j.clinthera.2013.01.010. Epub 2013 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'This study is intended to evaluate the pharmacodynamics, safety, and tolerability of LX4211 when administered concurrently with sitagliptin (Januvia®) in patients with Type 2 Diabetes Mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 to 65 years of age\n* History of Type 2 Diabetes Mellitus for at least 3 months prior to Screening, with HgbA1c values of 6.5 to 10.5% and C-peptide ≥1.0 ng/mL\n* Body mass index (BMI) ≤45 kg/sq m\n* Willing and able to self-monitor blood glucose\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes\n* Current use of any blood glucose lowering agent other than metformin\n* History of renal disease or clinically significant abnormal kidney function tests at Screening or Day -2\n* Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or Day -2\n* History of myocardial infarction, severe/unstable angina, or coronary revascularization procedure within 6 months of Day -2\n* History of clinically significant cardiac arrhythmias within 1 year of Day -2\n* Congestive heart failure and/or New York Heart Association (NYHA) class III or IV symptoms of heart failure\n* Subjects with uncontrolled Stage 3 hypertension\n* History of 2 or more emergency room visits, doctor's visits, or hospitalizations due to hypoglycemia within 6 months of Day -2\n* History of alcohol or drug abuse within 12 months of Screening\n* History of bowel resection \\> 20 cm, any malabsorptive disorder, severe gastroparesis, and GI procedure for the purpose of weight loss that would slow gastric emptying\n* History of HIV or hepatitis C\n* Major surgery within 3 months of Day -2 or any planned surgery during the study\n* History of any active infection within 2 weeks of Day -2\n* History of pancreatitis\n* History of any malignancy within the last 5 years which would affect the diagnosis or assessment of LX4211 or sitagliptin\n* History of any serious adverse reaction or hypersensitivity to LX4211 or sitagliptin\n* Presence of any clinically significant physical, laboratory, or ECG findings or any concurrent condition at Screening that may interfere with the study in the opinion of the investigator\n* Triglycerides \\> 1000 mg/dL at Screening or Day -2\n* Donation or loss of \\>400 mL of blood or blood product within 8 weeks prior to Day -2\n* Use of any tobacco product for the duration of study participation\n* Use of corticosteroids within 2 weeks of Day 1\n* Use of digoxin or warfarin within 2 weeks prior to Screening"}, 'identificationModule': {'nctId': 'NCT01441232', 'briefTitle': 'A Study to Evaluate the Pharmacodynamic Effects of Single-Dose Co-Administration of LX4211 With Januvia® in Type 2 Diabetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexicon Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Open-label, 3-period, 3-treatment, Single Dose Crossover Study to Evaluate the Pharmacodynamic Effects of LX4211 When Administered Concurrently With JANUVIA® (Sitagliptin) in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'LX4211.1-105-DM'}, 'secondaryIdInfos': [{'id': 'LX4211.105', 'type': 'OTHER', 'domain': 'Lexicon Pharmaceuticals, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'interventionNames': ['Drug: LX4211']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'interventionNames': ['Drug: LX4211', 'Drug: Januvia®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment B', 'interventionNames': ['Drug: Januvia®']}], 'interventions': [{'name': 'LX4211', 'type': 'DRUG', 'description': '400 mg of LX4211 administered as two 200 mg tablets', 'armGroupLabels': ['Treatment A', 'Treatment C']}, {'name': 'Januvia®', 'type': 'DRUG', 'description': '100 mg Januvia® (sitagliptin) administered as one 100 mg sitagliptin tablet', 'armGroupLabels': ['Treatment B', 'Treatment C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Lexicon Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Ikenna Ogbaa, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lexicon Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lexicon Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}