Effects of Antidiabetic Medications on the Postprandial State in Prediabetes

What Was Tested

This registered phase 4 trial tested Exenatide.

This project addresses cardiovascular disease risk in patients with prediabetes.

Levels of lipids after eating a meal ("postprandial lipids") are strong independent predictors of cardiovascular risk.

Newer anti-diabetic agents - exenatide and saxagliptin - impact lipid metabolism.

It had 12 arms (groups): Exenatide, then Saxagliptin, then Placebo (experimental), Exenatide, then Placebo, then Saxagliptin (experimental), Saxagliptin, then Exenatide, then Placebo (placebo comparator), Saxagliptin, then Placebo, then Exenatide (experimental) and Placebo, then Exenatide, then Saxagliptin (experimental).

The registry classes the interventions as drug and other.

More on the Plan

Postprandial lipid concentrations are a strong predictor of cardiovascular risk, independent of traditional cardiovascular risk factors.

The new classes of antidiabetic medications - GLP-1 agonists and DPP-IV inhibitors - affect lipid as well as glucose metabolism.

Each subject will participate in each of the three arms, which are three separate, daylong outpatient studies.

For each study arm, subjects will eat a standardized atherogenic high-fat test lunch.

Who Took Part

21 actual participants took part.

It was open to people of any sex aged from 30 years up to 70 years.

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

Examples of who could join: BMI between 30-35 kg/m2 (±1 kg/m2). Body weight has been stable (±4-5 pounds) over the prior three months.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes mellitus; history of diabetic ketoacidosis or hyperosmolar nonketotic coma; pregnant or breastfeeding women.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

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

In the crossover set-up each of the participants took both Exenatide and the comparison in turn, acting as their own control.

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, investigator and outcomes assessor.

It started in 2014-04 with completion listed for 2017-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Monocyte NfkB Levels as Detected by Western Blotting (time frame: baseline). Monocyte NfkB Levels as Detected by Western Blotting (time frame: 2 hours after ingestion of meal).

It also tracked 11 secondary outcomes, for example Triglycerides, Triglycerides, Triglycerides, Triglycerides, Free Fatty Acids and Free Fatty Acids.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 21 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.