Comparison of Insulin Mix25 Versus Mix50

What Was Tested

This registered phase 4 trial tested Insulin Lispro.

It had two arms (groups): Insulin Lispro Mix25 (experimental) and Insulin Lispro Mix50 (experimental).

Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.

Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 403 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: Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) for at least 6 months. Have been taking sulfonylureas, biguanide, thiazolidinedione, alpha-glucosidase inhibitor, glinide, or dipeptidyl peptidase IV inhibitor, or any combination of these. Have a body mass index (BMI) ≥18.5 and \<35.0 kilogram per square meter (kg/m²). Have given written informed consent to participate in the study in accordance with local regulations and the ethical review board (ERB) governing the study site.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Lispro and who got the comparison, which limits bias.

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

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

It started in 2013-01 with completion listed for 2014-08.

It ran at 27 sites in Japan (11), China (8), South Korea (5) and Turkey (Türkiye) (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (time frame: Baseline, Week 26).

It also tracked 6 secondary outcomes, for example Change From Baseline in Fasting Blood Glucose (FBG) at Week 26, Change From Baseline in Body Weight at Week 26 and Number of Hypoglycemic Events Baseline Through Week 26 (Incidence).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Lispro in 403 people.

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

More context: the Insulin Lispro compound page, all human trials.