Effect of Liraglutide on Weight and Appetite in Obese Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 2) is built around Liraglutide.

This trial is conducted in Europe.

The aim of the trial is to investigate the effect of NNC 90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated with diet and/or sulphonylurea or repaglinide.

It had two arms (groups): NNC 90-1170 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 35 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 mellitus. Diet treated and/or subjects in monotherapy with sulphonylurea or repaglinide. Body mass index (BMI) at least 27 kg/m\^2.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: impaired liver function; impaired renal function; cardiac problems.

How the Study Was Run

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

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2001-06 with completion listed for 2002-03.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in weight.

It also tracked 8 secondary outcomes, for example Total fat mass (assessed by use of DEXA (dual energy X-ray absorptiometry) scan), Waist circumference, Spontaneous energy intake assessed in connection to the ad libitum lunch meal, Appetite assessed in connection with the fixed breakfast meal (assessed by the use of VAS (visual analogue scale)), Gastric emptying rate and Energy expenditure.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 35 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.