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

What Was Tested

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

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

The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes.

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

The registry classes the interventions as drug.

Who Took Part

629 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. BMI (Body Mass Index) below or equal to 35.0 kg/m\^2. For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228).

The full record lists 5 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

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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

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 2009-09-01 with completion listed for 2010-11-08.

It ran at 91 sites in United States (59), Russia (8), United Kingdom (8), France (7), Germany (6) and South Africa (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment (time frame: Week 0, Week 52). Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) (time frame: Week 0 to Week 104 + 7 days follow up). Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes (time frame: Week 0 to Week 104 + 7 days follow up).

It also tracked 6 secondary outcomes, for example Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes, Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment, Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment, Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes, Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes and Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 629 people.

With 629 participants it is a large trial for this field.

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.