Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine.

Secondary Objectives: * To compare insulin glargine (U300) and Lantus in terms of occurrence of hypoglycemia and nocturnal hypoglycemia. * To compare insulin glargine (U300) and Lantus in terms of reaching target HbA1c values (all and reaching target without hypoglycemia). * To compare insulin glargine (U300) and Lantus in terms of controlled plasma glucose (all and reaching target without hypoglycemia). * To compare the frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe, probable and relative). * To assess the safety and tolerability of insulin glargine (U300). * To assess the development of anti-insulin glargine antibodies (AIA).

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

Toujeo - Insulin glargine (U300) will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks.

Lantus - Insulin glargine will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks.

The registry classes the interventions as drug.

More on the Plan

The total maximum study duration per patient will be 29 weeks that will consist of a 2-week screening period, 26-week treatment period, and a 2-day post-treatment safety follow-up period.

Who Took Part

Enrollment: 604 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 patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s). Signed written informed consent.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: age \< legal age of adulthood; history of type 2 diabetes mellitus for less than 1 year before screening; less than 6 months before screening with non-insulin antihyperglycemic treatment.

How the Study Was Run

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

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.

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

It started in 2016-08-24 with completion listed for 2018-08-06.

It ran at 54 sites in China (39), South Korea (11) and Taiwan (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c from baseline (time frame: Baseline, 6 months).

It also tracked 12 secondary outcomes, for example Percentage (%) of patients with at least one hypoglycemia, Percentage (%) of patients with at least one nocturnal hypoglycemia, Percentage (%) of patients requiring rescue therapy, Change in fasting plasma glucose, Change in 8-point Self-monitored Plasma Glucose (SMPG) profiles and Change of mean 24-hour plasma glucose.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 604 people.

With 604 participants it is a large trial for this field.

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.