Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

What Was Tested

This registered phase 3 trial tested Liraglutide.

This trial was conducted in Japan.

It had two arms (groups): Liraglutide + an OAD therapy (experimental) and Two OADs combination therapy (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 363 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

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

Examples of who could join: Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.). Type 2 diabetes mellitus (clinically diagnosed) for at least 6 months. Body Mass Index (BMI) below 40.0 kg/m\^2. Subjects able and willing to perform self-monitoring of plasma glucose (SMPG).

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer); calcitonin above or equal to 160 pg/ml; personal history of non-familial medullary thyroid carcinoma.

How the Study Was Run

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

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

Being open-label, the Liraglutide study did not mask who received what.

It started in 2012-01-10 with completion listed for 2013-04-26.

It ran at 36 sites in Japan (36).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence of Treatment Emergent Adverse Events (AEs) (time frame: Week 0 to Week 52 + 7 days).

It also tracked 3 secondary outcomes, for example Number of Confirmed Hypoglycaemic Episodes, Change in HbA1c From Baseline to Week 52 and Change in FPG From Baseline to Week 52.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 363 people.

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

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