Effect of Chronic Exenatide Therapy on Beta Cell Function and Insulin Sensitivity in T2DM

What Was Tested

This registered phase 4 trial tested Exenatide.

In this study, the researchers hope to learn about SGLT2 inhibition on EGP (endogenous glucose production) and plasma glucose concentration in diabetic subjects.

It had four arms (groups): Byetta / Bydureon (active comparator), Dapagliflozin (active comparator), Byetta/Bydureon plus Dapagliflozin (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 90 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: BMI = 25-35 kg/m\^2. Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included.

The full record lists 5 inclusion and 21 exclusion criteria; among the exclusions: uncontrolled thyroid disease , cushing's syndrome, congenital adrenal hyperplasia or hyperprolactinemia; untreated or poorly controlled hypertension (sitting blood pressure \> 160/95 mm hg); prior history of a malignant disease requiring chemotherapy, prior history of bladder cancer regardless treatment.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-12-15 with completion listed for 2022-07-14.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Endogenous Glucose Production (EGP) After 16 Weeks of Treatment With Each Study Drug (time frame: 16 weeks).

It also tracked 3 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG) Concentration, Change in Plasma Glucagon Concentration and Change in Plasma Insulin Concentration.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 90 people.

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.