Lispro Mix 25 vs. Glargine in Type 2 Diabetics

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Insulin Lispro.

In patients with type 2 diabetes who have not been on insulin therapy before the study will achieve better glycemic control by the treatment regiment consisting of two times daily insulin lispro mix 25 than by the treatment regiment with consisting of one time daily injection of insulin glargine.

It had two arms (groups): 2 (active comparator) and 1 (active comparator).

Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.

Lispro mix 25 SC twice-daily in conjunction with oral antidiabetic medications.

The registry classes the interventions as drug.

More on the Plan

The objective of this study is to investigate which type of insulin regimen is the best way to achieve best glycemic control in early type 2 diabetes.

Patients with diabetes mellitus type 2 with a duration of diabetes between 1 and 10 years without previous insulin therapy will be randomized on insulin lispro mix 25 or insulin glargine therapy.

Glycemic control will be compared by the between treatment difference in fasting plasma glucose and 2h postprandial blood glucose excursions (preprandial -postprandial excursions) after breakfast.

Who Took Part

53 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: Males or females who have type 2 diabetes between 1 and 10 years. Have not been on insulin treatment within 3 months before entry into the study. Have a body mass index below 40 kg/m².

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: have a known allergy to insulin; have known proliferative retinopathy.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2002-11 with completion listed for 2003-07.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast (time frame: 16 weeks or end of study).

It also tracked 7 secondary outcomes, for example Hemoglobin A1c measured at endpoint, Change of hemoglobin A1c from baseline to endpoint, Glycemic control as determined by self-monitored blood glucose concentrations, The incidence and rate of self-reported hypoglycemic episodes, Body mass index (BMI) and Body weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 53 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 Lispro compound page, all human trials.