Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes

What Was Tested

The trial (phase 4) is built around Insulin Lispro.

It had two arms (groups): Mix 50/50 (experimental) and Usual insulin regimen (active comparator).

Usual insulin regimen of insulin, Long-Acting and Insulin: 3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to women only aged from 18 years up to 44 years.

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

Examples of who could join: Pregnant and at least 13 weeks gestation. Failed diet therapy.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: \<18 years old or over 45 years old; urine dipstick \>2+ protein; blood pressure \>140/80 mmhg.

How the Study Was Run

The set-up was 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.

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

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 2008-10 with completion listed for 2010-06.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hemoglobin A1C (time frame: During Pregnancy (at approximately 28 weeks gestation)).

It also tracked 1 secondary outcome, for example Birthweight of Infant.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Lispro in 40 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.