A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics

What Was Tested

The trial (phase 1) is built around Insulin Glargine and Insulin Lispro.

This study will look into insulin sensitivity (how the body responds to insulin) and effects of meals on type 2 diabetics comparing insulin peglispro to insulin glargine.

The study has two treatment periods, each of which will last about four weeks.

One drug (insulin peglispro or insulin glargine) will be administered in each period.

It had two arms (groups): Insulin Peglispro (with Insulin Lispro) (experimental) and Insulin Glargine (with Insulin Lispro) (active comparator).

Insulin peglispro, a once daily subcutaneous(SC) injection at bedtime for 5 weeks.

Insulin glargine, a once daily subcutaneous(SC) injection at bedtime for 5 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Stable glycated hemoglobin (HbA1c) less than (\<) 10.0 percent (%). C-peptide \<0.3 nanomole per liter (nmol/L). Stable body during the last 2 months.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

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 2014-07 with completion listed for 2015-06.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 5 secondary outcomes, for example Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine and Insulin Lispro in 24 people.

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

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

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