Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 708 actual participants took part.

It was open to people of any sex aged from 30 years up to 70 years.

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

Examples of who could join: Insulin-naïve type 2 diabetes mellitus. Type 2 diabetes mellitus diagnosed for at least 1 year. BMI \< 40 kg/m². Informed consent obtained in writing at enrolment into the study. Willingness and ability to comply with the study protocol.

The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: treatment with glp-1 agonists or with dpp-iv inhibitors in the 3 months prior to study entry; treatment with tzd as monotherapy; diabetes mellitus other than type 2 (e.g. secondary to pancreatic disorders, drugs or chemical agents intake...).

How the Study Was Run

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

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.

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

It started in 2009-07 with completion listed for 2012-07.

It ran at 87 sites in Czechia (11), Romania (11), Slovakia (8), Brazil (7), Russia (7) and France (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: Recorded at baseline (week 0), week 12, week 24 and week 36).

It also tracked 5 secondary outcomes, for example Self-monitored fasting plasma glucose (FPG), 8-points profiles, Episodes of hypoglycemia and Need of additional prandial insulin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 708 people.

With 708 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.