Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

What Was Tested

The trial (phase 3) is built around Insulin Aspart and Insulin Detemir.

This trial is conducted in Asia, Europe, Japan and South America.

It had two arms (groups): IDeg OD (experimental) and IDet (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 456 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 mellitus for at least 12 months. Current treatment with any basal bolus insulin for at least 12 months. Body Mass Index (BMI) below or equal to 35.0 kg/m\^2. For Japan only: Minimum age is 20 years. For the extension trial only: Completed the six-month treatment period in trial NN1250-3585 (NCT01074268).

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: use of any other antidiabetic drug than insulin within the last 3 months; cardiovascular disease within the last 6 months; uncontrolled treated/untreated severe hypertension.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

The Insulin Aspart group and the comparison group ran side by side rather than switching.

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

It started in 2010-02 with completion listed for 2010-12.

It ran at 69 sites in Japan (15), United Kingdom (14), Italy (12), India (10), Finland (8) and Brazil (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 Treatment Emergent Adverse Events (AEs) (time frame: Week 0 to Week 52 + 7 days follow up).

It also tracked 9 secondary outcomes, for example Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment, Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26, Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52, Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment, Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment and Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 456 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Aspart compound page and the Insulin Detemir compound page, all human trials.