The Potential of Dapagliflozin Plus Exenatide in Obese Insulin-resistant Patients

What Was Tested

This registered phase 3 trial tested Exenatide and Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

It had three arms (groups): Dapagliflozin plus Exenatide (experimental), Placebo plus Placebo (placebo comparator) and Placebo plus Exenatide (active comparator).

The registry classes the interventions as drug.

Who Took Part

13 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Informed Consent can be obtained prior to any study procedures. Patient is able to read, understand and sign the Informed Consent. Currently treated with a stable TDID a set amount at least 3 months prior to enrolment. BMI of ≥ 30 kg/m2 at enrolment. Male or female and ≥18 and ≤75 years old at time of informed consent.

The full record lists 16 inclusion and 33 exclusion criteria; among the exclusions: diagnosis of type 1 diabetes; history of diabetic ketoacidosis, hyperosmolar coma or corticosteroid-induced type 2 diabetes; patients with history of acute or chronic pancreatitis.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The insulin resistance, prediabetes & type 2 diabetes participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the insulin resistance, prediabetes & type 2 diabetes participants stayed in one arm throughout.

Blinding on both sides kept the insulin resistance, prediabetes & type 2 diabetes participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant and investigator.

It started in 2018-02-19 with completion listed for 2019-04-01.

It ran at 4 sites in Germany (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c from baseline (week 0) to week 28 (time frame: 28 weeks).

It also tracked 6 secondary outcomes, for example Change in HbA1c from baseline (week 0) to week 14, Change in total body weight from baseline (week 0) to week 14 and 28, Change in BMI from baseline (week 0) to week 14 and 28, Change in FPG from baseline (week 0) to week 14 and 28 and Change in TDID from baseline (week 0) to week 14 and 28.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Insulin (regular human) in 13 people with insulin resistance, prediabetes & type 2 diabetes.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page and the Insulin (regular human) compound page, Insulin resistance, prediabetes & type 2 diabetes research.