Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Glargine and Insulin Aspart.

This trial is conducted in Europe.

The objective of the study is to investigate the effect and safety of continously basal delivered insulin aspart given by a pump versus once daily injection of insulin glargine.

The registry classes the interventions as device and drug.

Who Took Part

22 actual participants took part.

It was open to people of any sex aged from 30 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 for more than 2 years. BMI 25 - 40 kg/m2.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: known or suspected allergy to trial product(s) or related products; previous randomisation in this trial; mental incapacity, unwillingness or language barriers precluding adequate understanding and co-operation.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2005-05 with completion listed for 2006-01.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Variation in morning FPG (time frame: Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge).

It also tracked 2 secondary outcomes, for example Variation of plasma endogenous insulin and insulin aspart/glargine collected in hospital on the last 5 days and the morning on discharged and Variation of pre-dinner plasma glucose collected in hospital on the last 3 days.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine and Insulin Aspart in 22 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 Glargine compound page and the Insulin Aspart compound page, all human trials.