Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)

What Was Tested

The trial (phase 3) is built around Insulin Glargine.

It had two arms (groups): one (experimental) and Lantus® (active comparator).

Receive Lantus®.

The registry classes the interventions as drug.

More on the Plan

Patients with an established diagnosis of T2DM per ADA 2014 criteria and who satisfy the selection criteria will be included in the trial.

After the treatment period, there will be a follow-up visit; 4 weeks after the patient has been put back on approved medications.

Who Took Part

The registry lists 560 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Patients with an established diagnosis of T2DM per ADA 2014 criteria who also fulfill the following:. Diagnosis established 1 year prior to screening. Body mass index (BMI) of 18.50 to 40.00 kg/m2 at screening (both values inclusive). Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening; this information will be collected by patient interview during medical history.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: patients requiring basal-bolus insulin therapy or who in the opinion of the investigator require mealtime insulin in order to achieve glycemic control; regular use of immune-modulator therapy in the 1 year prior to screening; history of ≥1 episode of hyperglycemic hyperosmolar coma or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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 2014-08 with completion listed for 2015-12.

It ran at 120 sites in United States (94), Slovakia (13), South Africa (6), South Korea (3), Jordan (2) and Taiwan (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c From Baseline to 24 Weeks (time frame: 24 weeks).

It also tracked 6 secondary outcomes, for example Rate of Hypoglycemic Events Per 30 Days, Hypoglycemia Occurrence, Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time and Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 560 people.

With 560 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.