Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine and Insulin Aspart.

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

The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1006 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: For MAIN period (NN1250-3582):. Type 2 diabetes mellitus for at least 6 months. Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start. Body Mass Index (BMI) below or equal to 40.0 kg/m\^2. For EXTENSION period (NN1250-3667):.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: for main period (nn1250-3582):; treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months; cardiovascular disease within the last 6 months.

How the Study Was Run

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

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.

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

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

It started in 2009-09-01 with completion listed for 2010-10-28.

It ran at 136 sites in United States (66), Italy (13), Spain (11), Germany (9), Russia (8) and Bulgaria (7).

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 Confirmed Hypoglycaemic Episodes (time frame: Week 0 to Week 78 + 7 days follow up). Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes (time frame: Week 0 to Week 78 + 7 days follow up).

It also tracked 5 secondary outcomes, for example Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment, Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52, Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78, Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes and Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 1006 people.

With 1006 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.