Comparison of a New Formulation of Insulin Glargine With Lantus® in Japanese Patients With Type 1 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia.

It had two arms (groups): New formulation of insulin glargine (experimental) and Lantus (insulin glargine) (active comparator).

Once daily in the evening on-top of mealtime insulin.

Once daily in the evening on-top of mealtime insulin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 243 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: Patients with type 1 diabetes mellitus.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: age \< 18 years at screening visit;; patients less than 1 year before screening visit on any basal plus mealtime insulin;; use of an insulin pump in the last 6 months before screening visit and/or plan to switch to insulin pump in next 12 months;.

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.

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 2012-09 with completion listed for 2013-10.

It ran at 22 sites in Japan (22).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from baseline in HbA1c (time frame: baseline, 6 months).

It also tracked 8 secondary outcomes, for example Change from baseline in FPG, Change from baseline in pre-basal insulin injection SMPG, Change from baseline in 8-point SMPG profiles, Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values), Change from baseline in variability of plasma glucose profile and Number of Patients with various types of Hypoglycemia Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 243 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.