The Effects of Short-Term Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients

What Was Tested

This registered phase 4 trial tested Exenatide and NPH Insulin (isophane).

It had two arms (groups): Exenatide (experimental) and Humulin-N (active comparator).

The registry classes the interventions as drug.

More on the Plan

The progressive nature of type 2 diabetes is one of the major challenges in the treatment of affected patients, and agents that could alter the natural history of this condition would add greatly to current treatment approaches.

The acute effect of GLP-1 and GLP-1 receptor agonists on beta-cells is stimulation of glucose-dependent insulin release, followed by enhancement of insulin biosynthesis and stimulation of insulin gene transcription.

The chronic action is stimulating beta-cell proliferation, induction of islet neogenesis, and inhibition of ß-cell apoptosis, thus promoting expansion of beta-cell mass, as observed in rodent diabetes and in cultured beta-cells.

They will visit their clinics every 2 weeks in the first 2 visits and then every 4 weeks for 20 weeks.

Who Took Part

Enrollment: 160 planned participants were the target.

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

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

Examples of who could join: Newly diagnosed type 2 diabetic patients. Age between 30 and 70 years old.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-11 with completion listed for 2014-12.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: the time of glycemic remission and remission rate (time frame: at one year). The time of monotherapy failure and monotherapy failure rate (time frame: 5 years).

It also tracked 3 secondary outcomes, for example Beta-cell function and insulin sensitivity calculated from OGTT, Comparison of A1C change, the proportion of subjects who reached the treatment target and Comparison of A1C change, the proportion of subjects who reached the treatment target.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and NPH Insulin (isophane) in 160 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page and the NPH Insulin (isophane) compound page, all human trials.