Comparison of a New Formulation of Insulin Glargine With Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus

What Was Tested

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

Secondary Objectives: To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose (SMPG) profile.

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 oral antihyperglycemic drug (OADs).

Once daily in the evening on-top of OADs.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 240 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.

The full record lists 0 inclusion and 11 exclusion criteria; among the exclusions: age \< 18 years at screening visit;; BMI(body mass index) ≥ 35 kg/m2 at screening visit;; diabetes other than type 2 diabetes mellitus;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2012-09 with completion listed for 2013-11.

It ran at 31 sites in Japan (31).

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 240 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.