Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes

What Was Tested

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

This trial is conducted in Europe, Oceania and the United States of America (USA).

The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.

It had three arms (groups): SIBA (D) (experimental), SIBA (E) (experimental) and IGlar (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 178 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Type 1 diabetes for at least one year. Treated with insulin for at least six months - any regimen.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: any systemic treatment with products which in the investigator's opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 3 months prior to randomisation.

How the Study Was Run

It was run as a randomized, parallel-group 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2008-01 with completion listed for 2008-06.

It ran at 33 sites in United States (9), Germany (7), Norway (6), Sweden (6) and Australia (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, Week 16).

It also tracked 12 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG), Mean of 9-point Self Measured Plasma Glucose Profile (SMPG), Rate of Major and Minor Hypoglycaemic Episodes, Rate of Nocturnal Major and Minor Hypoglycaemic Episodes, Rate of Treatment Emergent Adverse Events (AEs) and Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine and Insulin Aspart in 178 people.

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 Aspart compound page, all human trials.