Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

What Was Tested

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

It had two arms (groups): Insulin Glargine (experimental) and Liraglutide (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 978 actual participants took part.

It was open to people of any sex aged from 35 years up to 75 years.

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

Examples of who could join: Patients With Type 2 Diabetes diagnosed for at least 1 year,. Body Mass Index (BMI) between 25 and 40 kg/m2 inclusively,. Willingness and ability to comply with the study protocol,. Signed informed consent obtained prior to any study procedure.

The full record lists 9 inclusion and 25 exclusion criteria; among the exclusions: previous treatment with glucagon like peptide-1 analogues or insulin in the past year (except in case of temporary treatment for gestational diabetes, surgery, hospitalization...),; treatment with thiazolidinediones or α-glucosidases inhibitors within 3 months prior to study entry,; diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake),.

How the Study Was Run

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

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.

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 2010-07 with completion listed for 2012-10.

It ran at 136 sites in United States (45), France (14), Spain (10), Russia (8), Austria (7) and Netherlands (7).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 16 secondary outcomes, for example Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period, Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period, Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period, Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period, Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period and Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Liraglutide in 978 people.

With 978 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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