FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR)

What Was Tested

This registered phase 4 trial tested Exenatide and Insulin Glargine.

This has led to a review of current ways to normalize blood glucose control with basal bolus insulin and how to make blood glucose better.

It had two arms (groups): Insulin Glargine, metformin, exenatide (experimental) and glargine, metformin, prandial insulin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Potential explanations for these results include three closely related physiologic processes: glycemic variability, weight gain and hypoglycemia.

Too much variability of glucose, especially post-prandial hyperglycemia, poses the dilemma of how to achieve near-normal mean glucose and HbA1C levels without causing insulin-induced hypoglycemia and/or weight gain.

The primary outcome measure will be the change in the coefficient of variation of continuous glucose readings, as assessed by CGM.

Importantly, FLAT-SUGAR will plan, a priori, to assess glycemic variability using CGM.

Who Took Part

102 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: T2DM for \>12 months defined according to current ADA criteria. C-peptide \>0.5 ng/mL-after informed consent has been signed, samples will be drawn fasting and sent to a central lab. No expectation that participant will move out of clinical center area during the next 8 months, unless move will be to an area served by another trial center. Ability to speak \& read English.

The full record lists 7 inclusion and 15 exclusion criteria; among the exclusions: cannot have had any cardiovascular event or interventional procedure, (mi, stroke or revascularization) or been hospitalized for unstable angina within the last 3 months; inability or unwillingness to discontinue use of acetaminophen products during cgm use; inability or unwillingness to perform blood glucose testing a minimum of 3 times/per day.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

The Exenatide group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant and care provider.

It started in 2012-08 with completion listed for 2014-07.

It ran at 12 sites in United States (12).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Coefficient of Variation at 26 Weeks Minus Coefficient of Variation at Baseline (time frame: At baseline, 6 months of intervention).

It also tracked 2 secondary outcomes, for example Number of Participants With Hypoglycemia and Weight Change During Trial.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Insulin Glargine in 102 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 and the Insulin Glargine compound page, all human trials.