Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-25 @ 7:27 PM
Study NCT ID:
NCT02405260
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2015-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Add Glucokinase Activator to Target A1c
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': 'C000654432', 'term': 'TTP399'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'dispFirstSubmitDate': '2017-02-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-09', 'studyFirstSubmitDate': '2015-03-27', 'dispFirstSubmitQcDate': '2017-02-09', 'studyFirstSubmitQcDate': '2015-03-27', 'dispFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c (Glycosylated haemoglobin)', 'timeFrame': 'Day 1 to Day 168'}], 'secondaryOutcomes': [{'measure': 'HbA1c < 7% at 6 months', 'timeFrame': 'Day 1 to Day 168'}, {'measure': 'HbA1c < 6.5% at 6 months', 'timeFrame': 'Day 1 to Day 168'}, {'measure': 'Plasma Glucose Levels', 'timeFrame': 'Day 1 to Day 168'}, {'measure': 'Lipid Levels', 'timeFrame': 'Day 1 to Day 168'}, {'measure': 'Insulin Levels', 'timeFrame': 'Day 1 to Day 168'}, {'measure': 'Lactate Levels', 'timeFrame': 'Day 1 to Day 168'}, {'measure': 'C-peptide Levels', 'timeFrame': 'Day 1 to Day 168'}, {'measure': 'Glucagon Levels', 'timeFrame': 'Day 1 to Day 168'}, {'measure': 'Glucagon-like Peptide-1 Levels', 'timeFrame': 'Day 1 to Day 168'}, {'measure': 'Change in Body Weight', 'timeFrame': 'Day 1 to Day 168'}, {'measure': 'Adverse Events', 'timeFrame': 'Day 1 to Day 182'}, {'measure': 'Blood Pressure', 'timeFrame': 'Day 1 to Day 182'}, {'measure': 'Electrocardiogram Parameters', 'timeFrame': 'Day 1 to Day 182'}, {'measure': 'Hematology', 'timeFrame': 'Day 1 to Day 182'}, {'measure': 'Blood Chemistry', 'timeFrame': 'Day 1 to Day 182'}, {'measure': 'Urinalysis', 'timeFrame': 'Day 1 to Day 182'}, {'measure': 'Pulse', 'timeFrame': 'Day 1 to Day 182'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This trial is a multi-center, adaptive, randomized, double-blind, placebo- and active- controlled, parallel group, Phase 2 study in subjects with T2DM to evaluate the effect of TTP399 on HbA1c following administration for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A historical diagnosis of Type 2 Diabetes in accordance with the American Diabetes Association (ADA) guidelines, with diagnosis at least 6 months prior to Screening.\n* On a stable (for the last 3 months prior to screening) regimen of metformin monotherapy equivalent of at least 1000 mg once daily.\n* Males, females of childbearing potential (must have a negative pregnancy test and be willing to comply with protocol contraception), and females of non-childbearing potential.\n* Age 18 to 75 years, inclusive, at the time of screening.\n* HbA1c ≥7.0% and ≤9.5%.\n* Generally stable health without active infection or history of major surgery or significant injuries within the last year.\n\nExclusion Criteria:\n\n* Diagnosis of Type 1 diabetes mellitus, maturity-onset diabetes of the young, insulin-requiring Type 2 Diabetes, other unusual or rare forms of diabetes mellitus, or history of diabetic ketoacidosis.\n* Clinically significant abnormal lab values including eGFR \\<50ml/min/1.73m2, ALT, bilirubin or AST \\>1.5 X ULN, hypokalemia or other clinically significant electrolyte abnormality.\n* History of myocardial infarction, unstable angina, coronary revascularization, stroke, or transient ischemic attack within 2 years of screening.\n* Presence of symptomatic congestive heart failure.\n* History of cardiac arrhythmias requiring treatment or prophylaxis with drugs or devices during the last 2 years or any history of atrial fibrillation or flutter beyond a single short-term episode (e.g., lasting 1-2 days).\n* History or presence of a 2nd degree or greater atrioventricular block in the absence of a pacemaker.\n* A 12-lead ECG, from screening or baseline demonstrating QTcF interval \\>450 msec for males or \\>47 msec for females.\n* A family or personal history of long QT syndrome.\n* History of pancreatitis.\n* Persistent, uncontrolled hypertension.\n* Presence of chronic active hepatitis (hepatitis B, hepatitis C, nonalcoholic steatohepatitis \\[NASH\\]) and/or known liver cirrhosis.\n* Participation in any formal weight loss program, or fluctuation of \\> 5% in body weight, or having received medications approved for weight loss within 3 months prior to screening.\n* A positive pre-study drug screen.\n* Participation in a clinical trial and receipt of an investigational product within 30 days.\n* Have a history of drug abuse within 2 years of screening or a positive pre-screen drug screen.\n* Have a history of hypoglycemic episode requiring glucose, glucagon, or orange juice administered by someone other than the patient within 6 months prior to screening.\n* A history of excessive alcohol consumption within the last 2 years prior to screening\n* Mental or legal incapacitation.\n* Blood donation of approximately 1 pint (500 mL) within 8 weeks.\n* History of MEN-2 or family history of medullary thyroid cancer.\n* History of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years prior study start.'}, 'identificationModule': {'nctId': 'NCT02405260', 'acronym': 'AGATA', 'briefTitle': 'Add Glucokinase Activator to Target A1c', 'organization': {'class': 'INDUSTRY', 'fullName': 'vTv Therapeutics'}, 'officialTitle': 'A Multi-Center, Adaptive Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled (Sitagliptin), Parallel Group Study to Evaluate the Safety and Efficacy of TTP399 Following 6 Months Administration in Subjects With Type 2 Diabetes Mellitus on A Stable Dose of Metformin', 'orgStudyIdInfo': {'id': 'TTP399-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TTP399 400 mg', 'description': 'TTP399 once daily', 'interventionNames': ['Drug: TTP399 400 mg']}, {'type': 'EXPERIMENTAL', 'label': 'TTP399 800 mg', 'description': 'TTP399 once daily', 'interventionNames': ['Drug: TTP399 800 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin 100 mg', 'description': 'Sitagliptin once daily', 'interventionNames': ['Drug: Sitagliptin 100 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TTP399 400 mg', 'type': 'DRUG', 'description': 'once daily', 'armGroupLabels': ['TTP399 400 mg']}, {'name': 'TTP399 800 mg', 'type': 'DRUG', 'description': 'once daily', 'armGroupLabels': ['TTP399 800 mg']}, {'name': 'Sitagliptin 100 mg', 'type': 'DRUG', 'description': 'once daily', 'armGroupLabels': ['Sitagliptin 100 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85741', 'city': 'Tuscon', 'state': 'Arizona', 'country': 'United States'}, {'zip': '91303', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '90056', 'city': 'Los Angeles', 'state': 'California', 'country': 'United 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37.97476, 'lon': -87.55585}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '29461', 'city': 'Moncks Corner', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.19632, 'lon': -80.01429}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78154', 'city': 'Schertz', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.55217, 'lon': -98.26973}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '99352', 'city': 'Richland', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 46.28569, 'lon': -119.28446}}], 'overallOfficials': [{'name': 'Carmen Valcarce, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'vTv Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'vTv Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}