Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients

What Was Tested

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

It had two arms (groups): Lantus + Apidra basal plus one (experimental) and NovoMix 30 Biphasic (active comparator).

Before randomization (common with arm 1): A 1 to 2 weeks of screening period: patients will continue on their current insulin and oral antidiabetic drug (OAD) therapy. 8 weeks of run-in period: patients will switch their treatment for insulin glargine (one daily injection at bedtime) and all OADs (with the exception of metformin) will be discontinued. After randomization: 24 weeks of treatment period: Insulin aspart/ insulin protamine crystallised insulin aspart (NovoMix® 30) + metformin (if applicable).

The registry classes the interventions as drug.

Who Took Part

The registry lists 463 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Type 2 diabetes mellitus. BMI \< or = 40 kg/m². Ability and willingness to perform blood glucose monitoring using a blood glucose meter and ability and willingness to use a patient diary. Provision of written informed obtained prior to enrollment in the study.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: type 1 diabetes mellitus; current or previous treatment with an insulin other than basal insulin (biphasic insulin, short acting insulin, rapid-acting insulin analogue); treatment with glp-1 receptor agonists or with dppiv inhibitors in the 3 months before screening.

How the Study Was Run

Design: 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.

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

It started in 2009-07 with completion listed for 2012-12.

It ran at 74 sites in United Kingdom (60) and Australia (14).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glycosylated Haemoglobin (HbA1c) (time frame: At week 7 and week 32).

It also tracked 3 secondary outcomes, for example Weight and Hypoglycaemia (total, severe and nocturnal).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 463 people.

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

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