Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)

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® plus insulin lispro.

The registry classes the interventions as drug.

Who Took Part

The registry lists 558 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 T1DM per ADA 2014 criteria. Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive).

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: history of use of animal insulin within the last 3 years or use of biosimilar insulin glargine at any time prior; history of use of a regular immunomodulator therapy in the 1 year prior to screening; history of ≥1 episodes of diabetic ketoacidosis 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 2014-06 with completion listed for 2016-07.

It ran at 162 sites in United States (72), Slovakia (20), Romania (11), Germany (10), Hungary (10) and South Africa (10).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c From Baseline to 24 Weeks (time frame: 24 weeks).

It also tracked 12 secondary outcomes, for example Summary of Actual and Change From Baseline in HbA1c, Change From Baseline in FPG Over Time, Change From Baseline in 8-point SMBG Profile Over Time, Rate of Hypoglycemic Events Per 30 Days Over Time, Hypoglycemia Occurrence and Occurrence of Local and Systematic Reactions.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 558 people.

With 558 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.