Safety and Tolerability of Liraglutide in Japanese Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 1) is built around Liraglutide.

This trial is conducted in Japan.

The aim of this trial is to assess the safety after multiple s.c.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 15 actual participants took part.

It was open to people of any sex aged from 20 years up to 64 years.

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

Examples of who could join: Type 2 diabetes. Duration of diabetes for more than 12 weeks. Subjects currently on diet therapy (OHA-naïve) or treated with OHA (oral hypoglycaemic agent). Monotherapy for more than 12 weeks. Body Mass Index (BMI): 18.5-30.0 kg/m\^2.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: recurrent severe hypoglycaemia; proliferative retinopathy or maculopathy requiring acute treatment; impaired hepatic function.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2003-12 with completion listed for 2004-03.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 24-hour profiles of serum calcitonin. 24-hour profiles of Ca2+ (ionised calcium). 24-hour profiles of PTH (Parathyroid Hormone).

It also tracked 7 secondary outcomes, for example Area under the plasma liraglutide curve, Cmax, maximum plasma liraglutide concentration, tmax, time to reach Cmax, Terminal phase elimination rate-constant, t½, terminal elimination half life and 24-hour profiles of serum insulin.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 15 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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