Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use

What Was Tested

This registered phase 4 trial tested Insulin (regular human) and Insulin Glargine.

The aim of this study is to observe changes in cardiovascular biomarkers during treatment with Lantus in patients with Type 2 Diabetes mellitus.

It had four arms (groups): NPH insulin + insulin glulisine (active comparator), NPH insulin + human insulin (active comparator), Insulin glargine + insulin glulisine (experimental) and Insulin Glargine + Human insulin (experimental).

Patients will be randomized to be treated with NPH insulin + Insulin Glulisine for 24 weeks.

Patients will be randomized to be treated with NPH insulin + human insulin for 24 weeks.

Patients will be randomized to be treated with insulin glargine + insulin glulisine for 24 weeks.

The registry classes the interventions as drug.

More on the Plan

To investigate the changes of * glucose, * intact proinsulin, * hsCRP, * adiponectin, * HbA1c * weight between visit 2 (baseline), visit 6 (12 weeks) and visit 8 (final visit after 24 weeks).

Overall total duration of the study is approximately 10 months.

Design: This is a randomized in four arms, open-label, multi-center study.

Population Patients with Type 2 Diabetes mellitus, Sample Size n = 60 (15 per arm).

Who Took Part

Enrollment: 60 planned participants were the target.

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: Give written informed consent. Patient consents that his/her family physician/diabetologist will be informed of trial participation. Type-2 diabetes mellitus ≥ 1 year of diagnosis (male and female). Experienced in self blood glucose measurement for ≥ 3 months. BMI \> 30 kg/m².

The full record lists 9 inclusion and 13 exclusion criteria; among the exclusions: history of drug or alcohol abuse within the last five years prior to screening; anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures; history of severe or multiple allergies.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2011-10 with completion listed for 2012-10.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Fasting Intact Proinsulin (time frame: Change from baseline at 24 weeks).

It also tracked 15 secondary outcomes, for example Weight, hsCRP, Adiponectin, MMP-9, OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks and HOMA-IR score.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Glargine in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Insulin Glargine compound page, all human trials.