Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients

What Was Tested

In this not phased trial, researchers set out to test Exenatide.

It had two arms (groups): GLP-1 (active comparator) and Normal saline (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

In the poorly controlled type 2 DM, insulin therapy is the treatment of choice to make sugar on target.

Actually, however, the general control rate is not good and partially due to the complex etiology in type 2 DM.

GLP-1 deficiency is the mostly emphasized in modern practice.

In order to study the effect of GLP-1 analogue in insulinized type 2 DM patients, investigators have to optimize the insulin therapy in the first priority.

Who Took Part

Enrollment: 51 actual participants took part.

It was open to people of any sex aged from 20 years up to 80 years.

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

Examples of who could join: Age \> 20 years old. DM diagnosed \> 2 years.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: severe comorbidity, including chf, cva, liver cirrhosis, copd, cushing's syndrome etc; psychologic problems, including anxiety; incorporation, including personal and familial factors.

How the Study Was Run

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

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

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

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

It started in 2011-10 with completion listed for 2013-06.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean amplitude of glycaemic excursions (MAGE) (time frame: During 6-day treatment course).

It also tracked 1 secondary outcome, for example homeostasis model assessment(HOMA).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide in 51 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, all human trials.