The Effect of the GLP-1 Analogue Exenatide on Type 2 Diabetes in CNS and Heart During Hyperglycemia Assessed by PET

What Was Tested

This registered phase 2, phase 3 trial tested Exenatide.

30 type 2 diabetic patients will be PET-scanned twice ( half of the patients heart-PET, half of the patients CNS-PET) in random order with infusions of placebo or GLP-1-analogue during hyperglycemic clamp to uncover the metabolic effects of GLP-1-analogues in perspectives of intervention of macrovascular late diabetic pathology such as stroke and AMI.

Earlier studies have revealed tendencies towards steady glucose metabolism in the CNS despite fluctuations in blood sugar when infusing native GLP-1.

It had two arms (groups): glp-1-analogue (active comparator) and placebo (placebo comparator).

During hyperglycemic clamp and GLP-1-analogue versus placebo infusion 15 patients will be heart OR CNS-PET scanned.

During hyperglycemic clamp and GLP-1-analogue versus placebo infusion 15 patients will be CNS OR heart-PET scanned.

The registry classes the interventions as drug.

More on the Plan

Apart from the individual burden on the patient, T2D puts massive pressure on national health economies.

It is well established that blood glucose lowering drugs, antihypertensive as well as lipid lowering drugs all play a pivotal role in the treatment of the type 2 diabetic subjects.

Regarding glycemia, there are frequently side effects with the 'classic' drugs such as hypoglycemia, weight gain, heart failure, and so forth.

Another important caveat is that employing the anti-hyperglycemic drugs either as monotherapy or in combination does not lower blood glucose to the targets as defined by the ADA.

Who Took Part

8 actual participants took part.

It was open to men only aged from 50 years up to 70 years.

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

Examples of who could join: Informed consent signed. Diabetes for \> 6 months. Diet treatment or a single OAD (metformin, SU). Age \> 50 years and \< 70 years. BMI 20-45 kg/m².

The full record lists 10 inclusion and 20 exclusion criteria; among the exclusions: other abnormal biochemical value; any of the following:; heart disease.

How the Study Was Run

Design: randomized, crossover and triple-blind.

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

Each person switched between Exenatide and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2010-02 with completion listed for 2010-11.

It ran at 4 sites in Denmark (4).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: steady glucose metabolism in the heart and brain during hyperglycemia with GLP-1-analogue infusion compared to placebo (time frame: oct. 2008 - oct 2010).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Exenatide in 8 people.

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

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.