Bexagliflozin Drug/Drug Interaction Study With Exenatide Injection
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This was a phase 1, single center, open-label, 2 × 2 crossover study designed to assess the
      effects of exenatide injection on the PK and PD of orally administered bexagliflozin tablets.
      Healthy subjects were randomly assigned to one of two groups with 10 subjects per group. Each
      group received both the treatments, alternately, in a crossover fashion with the two
      treatment periods separated by a 7-day washout period.

      In Treatment Period 1, subjects were admitted to the clinic on day 0, the day before dosing,
      and stayed in the clinic until 48 h post-dose. After an overnight fast of at least 10 h,
      subjects in Group 1 received a single oral dose of bexagliflozin tablets, 20 mg, alone 30 min
      before breakfast, and subjects in Group 2 received a subcutaneous (SC) injection of exenatide
      at 10 µg twice a day (bid) with an initial dose 30 min prior to a single oral dose of
      bexagliflozin tablets, 20 mg, and 1 hr before breakfast, followed by the second dose of
      exenatide alone 1 hr prior to the evening meal.

      In Treatment Period 2, subjects were admitted to the clinic on day 7, the day before dosing,
      and stayed in the clinic until 48 hr post-dose. After an overnight fast of at least 10 h,
      subjects in Group 1 received a SC injection exenatide at 10 µg bid with an initial dose 30
      min prior to a single oral dose of bexagliflozin tablets, 20 mg, and 1 hr before breakfast
      and followed by the second dose of exenatide alone 1 hr prior to the evening meal. Subjects
      in Group 2 received a single oral dose of bexagliflozin tablets, 20 mg, alone 30 minutes
      before breakfast.

      Blood samples for bexagliflozin plasma concentration were collected during each period at
      pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 hr post-dose. Pre-dose
      urine samples were collected from -12 to 0 hr for baseline measurement of PD parameters.
      Post-dose urine samples were collected in four batches: 0 to 12 hr, 12 to 24 hr, 24 to 36 hr,
      and 36 to 48 hr.

      Clinical laboratory tests and safety monitoring were conducted during both treatment periods
      for each group.
    

Intervention name(s): Bexagliflozin; Exenatide Injection
Intervention type(s): Drug; Drug
Intervention description(s): Bexagliflozin tablets, 20 mg; Byetta® (Exenatide), 10 ug, bid, subcutaneous injection
Other intervention name(s): Byetta®
Intervention MeSH terms: Exenatide; Bexagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment