Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019)

What Was Tested

This registered phase 4 trial tested Insulin Lispro.

Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administration.

It had two arms (groups): insulin lispro LM + insulin lispro MM (experimental) and Insulin Biphasic Aspart 30/70 or Insulin Lispro LM (active comparator).

Three times per day subcutaneous injection of insulin lispro mid mixture (MM) with the possibility to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.

Twice daily subcutaneous injection of either insulin biphasic aspart 30/70 or insulin lispro low mixture (LM) (continuation of analogue formulation used before study enrollment).

The registry classes the interventions as drug.

Who Took Part

The registry lists 302 actual participants took part.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: Have type 2 diabetes (World Health Organization \[WHO\] classification). Are at least 30 years of age and less than 75 years of age. Have a hemoglobin A1c 1.2 to 1.8 times the upper limit of the normal reference range at the local laboratory at Visit 1 or. Have given written informed consent to participate in this study in accordance with local regulations.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: are taking any other oral anti-diabetic medication (oam) not mentioned in inclusion criterion; have a body mass index greater than 40 kilograms per meter squared (kg/m2); have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.

How the Study Was Run

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

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

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

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

It started in 2006-10 with completion listed for 2009-03.

It ran at 9 sites in South Africa (3), Poland (2), Turkey (Türkiye) (2), Croatia (1) and Romania (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Hemoglobin A1c (HbA1c) at 16 Week Endpoint (time frame: 16 weeks).

It also tracked 9 secondary outcomes, for example Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint, 2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint, Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint, Mean Daily Blood Glucose Values at 16 Week Endpoint, Number of Patients With Self-reported Hypoglycemic Episodes and 30-Day Adjusted Rate of Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Lispro in 302 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.