An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes

What Was Tested

In this not phased trial, researchers set out to test Exenatide.

It had four arms (groups): Dapagliflozin Arm: (active comparator), Exenatide extended release Arm: (active comparator), Placebo Arm: (placebo comparator) and Exenatide extended release & dapagliflozin Arm: (active comparator).

The registry classes the interventions as drug.

More on the Plan

In the acute effects study, qualified patients will come fasting to the research center.

Review of study procedures and vitals will be performed.

Insulin infusion (pump) will be stopped and basal blood, urine and adipose tissue biopsy samples will be obtained.

Urine will be collected every hour up to 8 hours and a second adipose tissue biopsy will be collected at 6 hours after the start of the treatment.

Who Took Part

Enrollment: 70 actual participants took part.

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

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

Examples of who could join: Type 1 Diabetes for at least 1 year on continuous subcutaneous insulin infusion (CSII; also known as insulin pump). Ages 18-65 years (inclusive of ages 18 and 65). BMI 20-30 kg/m2.

The full record lists 4 inclusion and 35 exclusion criteria; among the exclusions: inability to give informed consent; inability or refusal to comply with protocol; use of glp-1 receptor agonists in the last 3 months or dpp-iv and sglt-2 inhibitors therapy in the last 1 month.

How the Study Was Run

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

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

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

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2016-11-01 with completion listed for 2021-02-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in Beta-hydroxybutyrate Levels in Blood (time frame: 12 weeks).

It also tracked 4 secondary outcomes, for example Change in HbA1c Following Treatment, Change in Urinary Beta-hydroxybutyrate (BHB) After 12 Weeks of Treatment and Change in Plasma Glucagon.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide in 70 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.