Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Insulin Lispro and NPH Insulin (isophane).

It had two arms (groups): NPH and insulin lispro (active comparator) and NPH and insulin glulisine (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 17 actual participants took part.

It was open to women only 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: Informed Consent to participate in clinical trial. Pregnant and 20-30 weeks gestation. Eat at least 2 meals per day.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: pregnant women \<18 years old; blood pressure \> 140/80 mmhg; pre-pregnancy bmi \> 40kg/m squared.

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.

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 2013-04 with completion listed for 2015-01-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Serum blood glucose area under the curve (AUC) at one 4-hour in-clinic meal challenge and Compare A1C at enrollment and weekly until delivery.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro and NPH Insulin (isophane) in 17 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Lispro compound page and the NPH Insulin (isophane) compound page, all human trials.