CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Bexagliflozin +1 moredrug
Likely dose
Bexagliflozin 20 mg (tablet formulation); Exenatide 10 mcg subcutaneously twice dailyAI-extracted
Key inclusion· 4
  • ✓Age 18-65 years, good health based on medical history, physical exam, ECG, and routine labs
  • ✓BMI 18.0-32.0 kg/m²
  • ✓Non-smoker for ≥3 months prior to screening
  • ✓Adequate venous access at multiple sites in both arms
Key exclusion· 12
  • ✕Clinically significant allergy to drugs or latex
  • ✕History of hypoglycemia
  • ✕Alcohol or drug dependence in the last 12 months
  • ✕Prior GLP-1 RA (including exenatide) within 3 months or any prior GLP-1 RA adverse reaction

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03167411
NCT03167411Phase 1Completed
CompareCT.gov

A Phase 1, Open-label, Randomized, Two-period, Two-treatment, Crossover Study to Evaluate the Effect of Exenatide on the Pharmacokinetics and Pharmacodynamics of Bexagliflozin in Healthy Subjects

Theracos·interventional·Posted May 30, 2017·Updated May 28, 2021

In Brief

A Phase 1 clinical trial evaluating Bexagliflozin and Exenatide Injection for Type2 Diabetes Mellitus. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the drug-drug interaction when given the study drug, bexagliflozin, with one of the most commonly prescribed glucagon-like peptide 1 receptor agonist (GLP-1 RA) exenatide. The study will also evaluate how safe the study drug is and how well the study drug is tolerated when administered with exenatide injection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType2 Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 30, 2017
Enrollment StartMay 24, 2017
Primary CompletionJun 29, 2017
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 9.1 years ago

Interventions

Bexagliflozindrug

Bexagliflozin tablets, 20 mg

Exenatide Injectiondrug

Byetta® (Exenatide), 10 ug, bid, subcutaneous injection