The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

What Was Tested

The trial (phase 3) is built around Liraglutide.

This trial is conducted in Africa, Asia, Europe and North America.

It had two arms (groups): IDeg + Lira (experimental) and Placebo + Lira (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 346 actual participants took part.

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: Type 2 diabetes. Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice daily (BID)).

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks; calcitonin equal to or above 50 pg/ml; current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma).

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

The Liraglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2012-10-01 with completion listed for 2013-12-31.

It ran at 132 sites in United States (67), France (11), Germany (9), Canada (7), Italy (7) and Israel (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) (time frame: Week 0, week 26).

It also tracked 8 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG), Change From Baseline in Mean Pre-breakfast Measurements Used for Titration, Change From Baseline in 8-point Profile, Change From Baseline in Mean of the 8-point Profile, Number of Hypoglycaemic Episodes and Number of Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 346 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.