Bexagliflozin Drug/Drug Interaction Study With Exenatide Injection

What Was Tested

This registered phase 1 trial tested Exenatide.

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.

It had two arms (groups): Bexagliflozin alone (experimental) and Bexagliflozin with exenatide injection (active comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Clinical laboratory tests and safety monitoring were conducted during both treatment periods for each group.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male and female subjects who were between the ages of 18 and 65 years, inclusive, in good health based on medical history, physical examination, electrocardiogram and routine laboratory tests. Subjects with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, inclusive. Subjects who were non-smokers for at least 3 months prior to screening. Subjects with adequate venous access at multiple sites in both arms. Subjects who were willing and able to be confined to the clinical research facility as required by the protocol.

The full record lists 6 inclusion and 23 exclusion criteria; among the exclusions: subjects with a history of hypoglycemia; subjects with a history of alcohol or drug dependence in the last 12 months; subjects who had previously received bexagliflozin, or any other sglt2 inhibitors within 3 months from the screening.

How the Study Was Run

The set-up was randomized, crossover and open-label.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Each person switched between Exenatide and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

It started in 2017-05-24 with completion listed for 2017-06-29.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cmax (Maximum Observed Plasma Concentration) (time frame: Up to 48 hrs). Tmax (Time of Maximum Observed Plasma Concentration) (time frame: Up to 48 hrs). T1/2 (Apparent Terminal Elimination Half-life) (time frame: Up to 48 hrs).

It also tracked 1 secondary outcome, for example Urinary Glucose Excretion (UGE).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, all human trials.