A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

This trial was conducted in Africa, Asia, Europe, North and South America.

It had two arms (groups): Insulin Degludec (experimental) and Insulin Glargine (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 833 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 (diagnosed clinically) for at least 6 months. Insulin naïve subjects (Allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days). BMI (Body Mass Index) below or equal to 40.0 kg/m\^2.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: treatment with tzds (thiazoledinedione), or glp-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to visit 1 (screening); previous participation in this trial. participation is defined as randomised. re-screening of screening failures is allowed only once within the limits of the recruitment period; known or suspected hypersensitivity to trial product(s) or related products.

How the Study Was Run

The set-up was 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.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2013-06-02 with completion listed for 2014-05-15.

It ran at 81 sites in China (33), United States (18), Canada (12), Romania (5), South Africa (5) and Ukraine (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in HbA1c (%) (Analysed by Central Laboratory) (time frame: Week 0, week 26).

It also tracked 5 secondary outcomes, for example Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes, Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory), Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose) and Number of Treatment Emergent AEs (Adverse Events).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 833 people.

With 833 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.