Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Exenatide and Insulin Aspart.

This is a multi-centre, open-label, randomized, parallel trial to compare the effect of Exenatide versus Biphasic insulin Aspart 30 on glucose variability and inflammatory markers in type 2 diabetes mellitus (T2DM) patients inadequately controlled with metformin monotherapy.

It had two arms (groups): Exenatide (experimental) and Biphasic insulin Aspart 30 (active comparator).

The registry classes the interventions as drug.

More on the Plan

The present randomized controlled trial was designed with primary aim to evaluate glycaemic fluctuation in the comparison between twice-daily Exenatide and other treatment paradigm (e.g. insulin Aspart 30).

Who Took Part

Enrollment: 150 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Provision of informed consent prior to any study specific procedures. Confirmed type 2 diabetes with history of at least half a year. Body mass index: 21-35 kg/m\^2.

The full record lists 6 inclusion and 24 exclusion criteria; among the exclusions: diagnosis or history of:; acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months; previous treatment with any dipeptide peptidase-4 (dpp4) inhibitor or glucagon-like peptide-1 (glp-1) receptor agonists within the past one year.

How the Study Was Run

Design: 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.

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

It started in 2015-11 with completion listed for 2018-04.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 11 secondary outcomes, for example HbA1c, Hours of hypoglycemia as measured by continuous glucose monitoring system (CGMS), Blood pressure, Lipids, Body mass index and Waist circumference.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Insulin Aspart in 150 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 Aspart compound page, all human trials.