Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-28 @ 6:52 PM
Study NCT ID:
NCT04673656
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2020-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
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': 'D002087', 'term': 'Butyrates'}], 'ancestors': [{'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2020-12-10', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in HOMA-IR', 'timeFrame': 'Baseline, Day 1, during the treatment period at days 21, 42, and 63, and at end of treatment period, Day 84', 'description': 'Changes in HOMA-IR at Days 21, 42, 63, and 84 using repeated measures ANCOVA'}], 'secondaryOutcomes': [{'measure': 'Changes in fasting low-density lipoprotein-cholesterol (LDL-C)', 'timeFrame': 'Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84', 'description': 'Changes in fasting low-density lipoprotein-cholesterol (LDL-C) at Days 1, 42, and 84'}, {'measure': 'Changes in fasting triglycerides', 'timeFrame': 'Baseline, Day 1, during the treatment period at days 42, and at end of treatment period, Day 84', 'description': 'Changes in fasting triglycerides at Days 1, 42, and 84'}, {'measure': 'Changes in HbA1c', 'timeFrame': 'Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84', 'description': 'Changes in HbA1c at Days 1, 42, and 84'}, {'measure': 'Changes in fasting glucose', 'timeFrame': 'Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84', 'description': 'Changes in fasting glucose at Days 1, 42, and 84'}, {'measure': 'Changes in fasting insulin', 'timeFrame': 'Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84', 'description': 'Changes in fasting insulin at Days 1, 42, and 84'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double-blind, placebo-controlled, dose-response study of BKR-017 and placebo that will be conducted at two investigative sites. The total duration of subject involvement is approximately 15 weeks; the screening period can be up to 3 weeks prior to the start of test period, followed by a 12-week test period. During the test period, subjects will self-administer three tablets of test product, two times daily: before breakfast and before bedtime.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females between the ages of 18 and 70 years at the time of screening, inclusive\n* Diagnosed with T2D and under the care of a healthcare professional for its management, or newly diagnosed (as participant in the study) with T2D\n* HbA1c 6.5% -10.5%, inclusive\n* Has given written informed consent to participate in this study\n* Willing to complete 84-day test period\n* Willing to maintain current diet and exercise routine and current prescription medications for the duration of the study\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* History of bariatric or intestinal surgery\n* Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis\n* Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator\n* History of heart disease that in the opinion of the investigator should exclude the subject from the study\n* Severely uncontrolled hypertension at screening defined as a systolic blood pressure \\> 180 mmHg or a diastolic blood pressure \\> 110 mmHg on the average of two seated measurements after being at rest for at least 5 minutes\n* Untreated or uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease\n* Active significant infection as determined by the investigator\n* Known allergy to butyrate or any of the components of the tablets\n* Subjects planning to make major changes to diet and physical activity during the trial duration\n* Participation in a clinical trial and/or treatment with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer)\n* Pregnant, nursing, or trying to become pregnant\n* In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study.\n* Subject is taking one or more of the excluded therapies."}, 'identificationModule': {'nctId': 'NCT04673656', 'briefTitle': 'Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioKier Inc.'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients', 'orgStudyIdInfo': {'id': 'CL-501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Test Group 1', 'description': 'Group 1 will receive 84 days of placebo BID', 'interventionNames': ['Dietary Supplement: BKR-017']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test Group 2', 'description': 'Group 2 will receive 84 days of 0.5 g of BKR-017 BID', 'interventionNames': ['Dietary Supplement: BKR-017']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test Group 3', 'description': 'Group 3 will receive 84 days of 1.0 g of BKR-017 BID', 'interventionNames': ['Dietary Supplement: BKR-017']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test Group 4', 'description': 'Group 4 will receive 84 days of 1.5 g of BKR-017 BID', 'interventionNames': ['Dietary Supplement: BKR-017']}], 'interventions': [{'name': 'BKR-017', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Butyrate'], 'description': 'Nutrient butyrate into a colon-targeted tablet formulation (BKR-017) is intended to stimulate secretion of GLP-1 from L-cells in the lower gut. Butyrate delivered to the colon in tablet form will not cause the side-effects seen with formation of butyrate by fermentation.', 'armGroupLabels': ['Test Group 1', 'Test Group 2', 'Test Group 3', 'Test Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Clinical Research at Pickett Road', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28081', 'city': 'Kannapolis', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Clinical & Translational Science Institute (CTSI)', 'geoPoint': {'lat': 35.48736, 'lon': -80.62173}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioKier Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}