Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Insulin Aspart.

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

It had three arms (groups): Flex + insulin aspart (experimental), Fixed + insulin aspart (experimental) and IGlar + insulin aspart (active comparator).

The registry classes the interventions as drug.

Who Took Part

493 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies. Body Mass Index (BMI) below or equal to 35.0 kg/m\^2.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: use within the last 3 months prior to visit 1 of any antidiabetic glucose lowering drug other than insulin; pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements; cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer).

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.

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

It started in 2010-03 with completion listed for 2010-11.

It ran at 82 sites in United States (40), United Kingdom (12), Germany (10), Norway (6), Belgium (5) and Greece (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment (time frame: Week 0, Week 26). Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes (time frame: Week 0 to Week 52 + 7 days follow up). Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes (time frame: Week 0 to Week 52 + 7 days follow up).

It also tracked 3 secondary outcomes, for example Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment, Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment and Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 493 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.