Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes

What Was Tested

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

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

The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued).

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1030 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 2 diabetes mellitus. Body Mass Index (BMI) no higher than 40.0 kg/m\^2. For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3579 (NCT00982644).

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: treatment with exenatide or liraglutide within the last 3 months before trial start; 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 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 with completion listed for 2010-12.

It ran at 187 sites in United States (86), Germany (18), Canada (16), Spain (11), Norway (8) and Austria (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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 104 + 7 days follow up). Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes (time frame: Week 0 to Week 104 + 7 days follow up).

It also tracked 5 secondary outcomes, for example Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes, Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 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 104 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 in 1030 people.

With 1030 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, all human trials.