Insulin Exposure and Glucose Response to Meals in Type 1 Diabetic Subjects Administered Two Different Insulin Regimens Compared to the Endogenous Insulin Exposure and Glucose Response to Meals In Healthy Adult Controls

What Was Tested

This registered not phased trial tested Insulin (regular human).

Hypoglycemia is often the major limiting factor in achieving good control.

It had two arms (groups): Apidra (insulin glulisine) (active comparator) and 70/30 insulin (active comparator).

Administration of Apidra at three meals during a 24 hour period.

Administration of 73/30 insulin at three meals during a 24 hour period.

The registry classes the interventions as drug.

More on the Plan

The researchers also will study healthy volunteers as controls who will not be treated with insulin but will be evaluated for mealtime absorption and blood glucose profile during similar meal intake.

The researchers will use a stable isotope tritiated glucose.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 12 adults (males or females) with Type 1 Diabetes, aged 18 to 55 years. Body mass index \< 29.0 kg/m2. 12 non-smoking adults (males or females), aged 18 to 55 years. Normal response to an oral glucose tolerance test (OGTT). Body mass index \< 29.0 kg/m2.

The full record lists 8 inclusion and 24 exclusion criteria; among the exclusions: diabetic subjects; history of acute metabolic complications within 3 months of the study; history of lipodystrophy.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

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

Only one side, usually the participants, was kept unaware of whether Insulin (regular human) was given.

Those kept unaware of assignments: participant.

It started in 2005-04 with completion listed for 2006-04.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Insulin levels (time frame: 24 hours).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 24 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 (regular human) compound page, all human trials.