A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine and Insulin Aspart.

This trial is conducted globally.

The aim of this trial is to compare stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled on oral anti-diabetic therapy.

It had two arms (groups): BIAsp (experimental) and IGlar + IAsp (active comparator).

The registry classes the interventions as drug.

Who Took Part

335 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female, age at least 18 years at the time of signing informed consent. Type 2 diabetes subjects clinically diagnosed at least 6 months prior to screening. Insulin-naïve. Short term insulin treatment for acute illnesses for a total of 14 days or less is allowed as is prior insulin treatment for gestational diabetes. Willing to consume 3 main meals daily (morning, mid-day and evening) throughout the entire trial. The definition for 'main meal' will be according to the investigator's discretion.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: impaired liver function, defined as alt (alanine aminotransferase) at least 2.5 times upper limit of normal (central laboratory value measured at screening visit); within the past 180 days prior to randomisation, any of the following: myocardial infarction, stroke or hospitalization for unstable angina and /or transient ischemic attack.

How the Study Was Run

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

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

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

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2015-08-31 with completion listed for 2016-09-20.

It ran at 41 sites in India (8), Australia (5), Bulgaria (5), Turkey (Türkiye) (5), South Korea (4) and Thailand (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 32).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 335 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page and the Insulin Aspart compound page, all human trials.