Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

It had two arms (groups): HOE901-U300 (experimental) and Lantus (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 878 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: Adult participants with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s);. Signed written informed consent.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: history of type 2 diabetes mellitus for less than 1 year before screening; less than 6 months before screening with non-insulin antihyperglycemic treatment; current or previous insulin use except for a maximum of 8 consecutive days (for example, acute illness, surgery) during the last year prior to screening.

How the Study Was Run

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

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2012-08 with completion listed for 2013-09.

It ran at 217 sites in United States (117), Canada (12), Japan (12), Romania (11), Denmark (9) and Hungary (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c From Baseline to Month 6 Endpoint (time frame: Baseline, Month 6).

It also tracked 12 secondary outcomes, for example Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6, Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint, Variability of Preinjection SMPG at Month 6 Endpoint, Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint, Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 and Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 878 people.

With 878 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.