Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study

What Was Tested

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

It had two arms (groups): Insulin glargine (experimental) and Premixed insulin (experimental).

The registry classes the interventions as drug.

Who Took Part

934 actual participants took part.

It was open to people of any sex aged from 35 years with no upper age limit.

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

Examples of who could join: Type 2 diabetes diagnosed for more than 1 year. Body mass index (BMI) ≤ 40 kg/m2. Willingness and ability to comply with the study protocol. Signed informed consent obtained prior any study procedure.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: treatment with glucagon-like peptide-1 (glp-1) agonists in the 3 months prior to study entry; previous treatment with insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week); diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-02 with completion listed for 2012-03.

It ran at 96 sites in China (12), Greece (10), Italy (10), Spain (9), Turkey (Türkiye) (9) and Taiwan (8).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example 7-point plasma glucose (PG) profile recorded on 3 consecutive days, Self-monitored PG (Plasma Glucose) values over 3 consecutive days, Self-monitored PG (Plasma Glucose) values over 3 consecutive days, Self-monitored PG (Plasma Glucose) values over 3 consecutive days, Weight and supine blood pressure and Biochemistry and lipid profile.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 934 people.

With 934 participants it is a large trial for this field.

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, all human trials.