Lantus Versus Levemir Treat-To-Target

What Was Tested

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

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

Insulin Glargine.

Insulin Detemir.

The registry classes the interventions as drug.

Who Took Part

973 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: Type 2 diabetes for at least 1 year. Body mass index (BMI) \< 40 kg/m². Ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: type 1 diabetes; current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week); treatment with glucagon-like peptide (glp)-1 receptor agonists or with dipeptidyl peptidase (dpp)-iv inhibitors.

How the Study Was Run

The set-up was 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 2006-11 with completion listed for 2008-06.

It ran at 20 sites in Australia (1), Brazil (1), Canada (1), Denmark (1), Finland (1) and Germany (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c recorded (time frame: At baseline, week 12 and week 24). Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm (time frame: On the 4 consecutive days before each visit). Self-monitored BG values from 8-point 24-hour profile recorded on 2 consecutive days (time frame: Within the week prior to baseline, week 12 and week 24).

It also tracked 9 secondary outcomes, for example Laboratory fasting plasma glucose, Insulinemia and fasting C-peptide level, Lipid profile, Patient reported outcomes (quality of life and treatment satisfaction), Safety data: occurrence of adverse events and weight and Waist and hip circumferences.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Detemir in 973 people.

With 973 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 and the Insulin Detemir compound page, all human trials.