Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)

What Was Tested

The trial (phase 2) is built around Insulin Aspart.

The order of treatment session will be randomised.

Secretion of endogenous insulin depends on exogenous insulin supply 2.

It had two arms (groups): Insulin Aspart without glucose supply (other) and Insulin Aspart with glucose supply (other).

Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply.

Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply.

The registry classes the interventions as drug.

More on the Plan

There are a screening visit and two treatment sessions: Session A: Treatment with Insulin Aspart 1.5 IE/time overnight without intravenous glucose infusion Session B: Treatment with Insulin Aspart 1.5 IE/time overnight with intravenous glucose infusion.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 35 years up to 75 years.

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

Examples of who could join: Subjects with type 2 diabetes mellitus. Women and men \>= 35 and \<= 75 years old. BMI 25-42 kg/m2, both values are included.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: suspected or known allergy to the trial drug or similar medications; treatment with hte drugs that after investigator judgment could potentially interfere with plasma glucose levels; heart: unstable angina pectoris, acute myocardial infarction within the last 12 months.

How the Study Was Run

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

Because people in this Insulin Aspart 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 Aspart and the comparison in turn, acting as their own control.

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2012-05 with completion listed for 2012-12.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Aspart in 10 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 Aspart compound page, all human trials.