Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients

What Was Tested

This registered phase 4 trial tested Exenatide and Insulin Lispro.

The randomized, controlled trial is to investigate and evaluate the effects of short-term continuous subcutaneous insulin infusion (CSII) sequential exenatide therapy on β-cell function, long-term glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients.

It had two arms (groups): insulin lispro injection, exenatide injection (experimental) and insulin lispro injection (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 effect of GLP-1 receptor agonists on beta-cells is stimulation of glucose-dependent insulin release, followed by enhancement of insulin biosynthesis.

It is stimulating beta-cell proliferation, induction of islet neogenesis, and inhibition of ß-cell apoptosis.

Exenatide is synthetic exendin-4, GLP-1 receptor agonist.

Who Took Part

The registry lists 156 actual participants took part.

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, drug naïve. Age 30\~70 years. Female patients of reproductive age should practice a reliable method of birth control throughout the study.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: acute or severe chronic diabetic complications; recently suffered from mi or cva; severe gastrointestinal disease.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

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 2012-08 with completion listed for 2015-02.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): the glycemic remission rate in different groups (time frame: one year).

It also tracked 2 secondary outcomes, for example the time of glycemic remission in different groups.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Insulin Lispro in 156 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page and the Insulin Lispro compound page, all human trials.