Effectiveness of Exenatide Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide.

It had three arms (groups): one (experimental), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Patients who meet all inclusion and none of the exclusion criteria will enter a 1-week Lead-in Period, during which patients will be given a blood glucose meter and fitted with a blinded Continuous Glucose Monitor (CGM) and undergo a 14-day CGM assessment.

After the 1-week Lead-in Period, approximately 60 subjects will be randomized at a 1:1:1 ratio to one of three open-label treatment arms to achieve approximately 20 subjects per treatment arm.

The study consists of a 2-week Screening Period, a 1-week Lead-in Period, a 14-week open-label Treatment Period and a 10-week Follow-up Period.

Who Took Part

67 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: Willing and able to give informed written consent prior to any tudy specific procedures. Male or female, age 18 to 75 years. Diagnosis of T2DM. Body mass index (BMI) \<45 kg/m2.

The full record lists 9 inclusion and 22 exclusion criteria; among the exclusions: involvement in the planning and/or conduct of the study (applies to both investigator staff and/or staff at the study site); previous enrolment in the present study; women who are pregnant, breastfeeding, or plan to become pregnant during the course of the study.

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.

Being open-label, the Exenatide study did not mask who received what.

It started in 2019-07-02 with completion listed for 2021-06-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: MAGE (time frame: 14 weeks).

It also tracked 7 secondary outcomes, for example Fasting Plasma Glucose, HbA1c, Weight, Blood Pressure, Blood Glucose Variability and 24 Hour Mean Blood Glucose.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 67 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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