The LANCET Trial: A Trial of Long-acting Insulin Injection to Reduce C-reactive Protein in Patients With Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

CRP is a marker of chronic low-level inflammation, a new risk factor for diabetes, heart attack, stroke, and other cardiovascular events.

It had four arms (groups): Placebo pill (placebo comparator), Metformin Pill (active comparator), Insulin Glargine plus placebo pill (active comparator) and Insulin Glargine plus metformin pill (active comparator).

Placebo pill.

Metformin pill.

Insulin glargine plus placebo pill.

The registry classes the interventions as drug.

More on the Plan

Study Rationale Low-grade systemic inflammation as indicated by elevated levels of C-reactive protein (CRP) is often present in patients with type 2 diabetes.

Investigational Plan This is a multicenter, community-based, randomized 2x2 factorial trial of Lantus and metformin among patients with type 2 diabetes treated with either diet or oral monotherapy (other than metformin) only who have poor glycemic control and elevated CRP.

The primary endpoint is change in CRP.

This study is designed to assess whether the use of Lantus either alone or in combination with metformin lowers CRP over a 14-week treatment period.

Who Took Part

500 actual participants took part.

It was open to people of any sex aged from 18 years up to 79 years.

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

Examples of who could join: Type 2 diabetes, treated only by diet or oral drugs other than metformin.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: baseline use of metformin or insulin; type 1 diabetes, history of ketoacidosis or positive anti-gad antibody; history of congestive heart failure requiring drug therapy.

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

It started in 2006-08 with completion listed for 2009-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 500 people.

With 500 participants it is a large trial for this field.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page, all human trials.