Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With Oral Antidiabetic Drugs (OADs) in Patients With Diabetes Mellitus, Type 2 (DMT2)

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

It had 1 arm (groups): single arm (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 117 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diabetes type 2. Ability and willingness to perform continuous glucose monitoring system / CGMS (examination within the study). Written informed consent obtained prior to enrollment in the study. Women are either not of childbearing potential or women of childbearing potential must not be pregnant and must use a reliable contraceptive measure for the duration of the study.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: pregnant women or women planning gravidity during clinical study protocol; history of hypersensitivity to the study drugs or to drugs with a similar chemical structure; likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-03 with completion listed for 2009-06.

It ran at 1 site in Czechia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The change in blood glucose variability (time frame: before start with insulin glargine treatment and at the end of the study).

It also tracked 4 secondary outcomes, for example Occurrence of adverse events, Development of diabetes compensation - fastig blood glucose and HbA1 and Development of weight of patients.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Glargine in 117 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.