Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients

What Was Tested

The trial (not phased) is built around Exenatide and Insulin Lispro.

The purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.

It had three arms (groups): Exenatide (active comparator), Premixed insulin analog (active comparator) and pioglitazone (active comparator).

The registry classes the interventions as drug.

More on the Plan

One of the fundamental defects in type 2 diabetes mellitus is declining β-cell function.

Exenatide targets multiple metabolic disturbances in type 2 diabetes and exerts direct effects on β-cell, which indicates that it may not only contribute to the glucose control but also delay disease progression.

However, no study has compared the effects of exenatide with other hypoglycemic therapies with β cell protective function in newly diagnosed and drug-naïve type 2 diabetic patients.

This current study is thus designed to evaluate the effects of exenatide, insulin and pioglitazone on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.

Who Took Part

Enrollment: 416 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 11 exclusion criteria; among the exclusions: acute or severe chronic diabetic complications; congestive heart failure (nyha grade ⅲ\~ⅳ); severe gastrointestinal disease.

How the Study Was Run

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

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 2010-08 with completion listed for 2012-08.

It ran at 25 sites in China (25).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks (time frame: 48 weeks).

It also tracked 3 secondary outcomes, for example β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio) and Safety and Tolerability in Different Groups.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide and Insulin Lispro in 416 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 Lispro compound page, all human trials.