Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Insulin Glargine.

This trial is conducted in Africa, Asia and North America.

The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

It had four arms (groups): SIBA (D) (experimental), SIBA (E) (experimental), SIBA (D) M, W, F (experimental) and IGlar (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 245 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.). Body Mass Index (BMI) 23-42 kg/m\^2 \[lb/in\^2 x 703\] (both inclusive).

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: metformin contraindication according to local practice; thiazolidinedione (tzd) treatment within previous three months prior to visit 1; any systemic treatment with products which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three months prior to randomisation.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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 2008-01 with completion listed for 2008-08.

It ran at 29 sites in United States (18), Canada (4), India (4) and South Africa (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, Week 16).

It also tracked 11 secondary outcomes, for example Mean of 9-point Self Measured Plasma Glucose Profile (SMPG), Rate of Major and Minor Hypoglycaemic Episodes, Rate of Nocturnal Major and Minor Hypoglycaemic Episodes, Rate of Treatment Emergent Adverse Events (AEs), Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) and Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine in 245 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, all human trials.