A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT02390050 |
Recruitment Status :
Completed
First Posted : March 17, 2015
Results First Posted : April 20, 2021
Last Update Posted : June 29, 2021
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Sponsor:
Theracos
Information provided by (Responsible Party):
Theracos
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Tracking Information | ||||
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First Submitted Date ICMJE | March 11, 2015 | |||
First Posted Date ICMJE | March 17, 2015 | |||
Results First Submitted Date ICMJE | March 25, 2021 | |||
Results First Posted Date ICMJE | April 20, 2021 | |||
Last Update Posted Date | June 29, 2021 | |||
Actual Study Start Date ICMJE | May 12, 2015 | |||
Actual Primary Completion Date | June 3, 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in HbA1c After 12 Weeks of Treatment [ Time Frame: 12 weeks ] Mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA) with baseline HbA1c as a covariate will be fit to the available data, incorporating all visits at which HbA1c was measured for each subject including scheduled visits at Weeks 2, 6, and 12 as well as unscheduled visits for measurements of HbA1c. Treatment (placebo, 5 mg, 10 mg, 20 mg), study center, prior anti-diabetic treatment status, study visit and treatment-by-visit interaction will be applied as fixed effects and subject as a random effect. The least square mean (LSM) change from baseline to Week 12 was analyzed using the Mixed-Effect Model Repeated Measure (MMRM) Analysis of Covariance (ANCOVA) model using 95% Confidence Intervals (CIs) for the between-group mean changes.
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Original Primary Outcome Measures ICMJE |
Dose Identification [ Time Frame: 12 weeks ] The primary objective of this study is to identify dose(s) for further clinical study through the comparison of HbA1c change from baseline in each active group that will receive bexagliflozin tablets, 5 mg, 10 mg, or 20 mg, to the placebo group over 12 weeks of treatment. To examine the dose response, tests for linear and quadratic dose-response relationships between the doses (0 [placebo], 5, 10 and 20 mg bexagliflozin) and the change from baseline in HbA1c at week 12 will be conducted using a general linear model and appropriate orthogonal polynomial contrasts.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures |
Population pharmacokinetic evaluation of bexagliflozin plasma concentration (bexagliflozin plasma concentration over time (sparsely sampled) [ Time Frame: 12 weeks ] Measurement of bexagliflozin plasma concentration over time (sparsely sampled) will also be conducted at 20 centers and will include approximately 240 study subjects as part of a bexagliflozin population PK study.
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Descriptive Information | ||||
Brief Title ICMJE | A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus | |||
Official Title ICMJE | A Phase 2b, Multi-center, Double-blind, Placebo-controlled, Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets on HbA1c in Subjects With Type 2 Diabetes Mellitus | |||
Brief Summary | The purpose of this study was to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin is an orally administered drug for the treatment of T2DM and is classified as a Sodium Glucose co-Transporter 2 (SGLT2) Inhibitor. This study was to enroll both treatment naive and those subjects previously treated with one oral hypoglycemic agent (OHA). Approximately 320 subjects eligible for randomization was to receive bexagliflozin tablets, 5, 10, 20 mg or placebo, once daily for 12 weeks in an outpatient setting. | |||
Detailed Description | The study was a phase 2b multicenter, double-blind, placebo-controlled parallel group study to assess the effect of once daily bexagliflozin tablets on HbA1c in either treatment-naïve T2DM subjects or in subjects who were treated with one oral anti-diabetic agent. Treatment naïve subjects were eligible if their HbA1c values were between 7% and 8.5% at the screening visit while subjects who were treated with one oral hypoglycemic agent (OHA) were eligible if their HbA1c value was between 6.5% and 8.5% at screening and underwent a 6 or 10 week washout period. In addition, all eligible subjects underwent a two week placebo run-in period and those who showed good compliance in taking study medication (i.e., missed no more than one dose during the run-in period) during this period and whose HbA1c values were between 7 and 8.5% at the end of the run-in period were eligible for randomization. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus, Type 2 | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
292 | |||
Original Estimated Enrollment ICMJE |
320 | |||
Actual Study Completion Date ICMJE | June 3, 2016 | |||
Actual Primary Completion Date | June 3, 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | The following subjects were eligible for randomization:
Subjects who exhibited any of the following characteristics were to be ineligible for randomization:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02390050 | |||
Other Study ID Numbers ICMJE | THR-1442-C-449 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Theracos | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Theracos | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Theracos | |||
Verification Date | June 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |