Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin

What Was Tested

This registered phase 4 trial tested Liraglutide.

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

It had two arms (groups): Liraglutide + metformin + sitagliptin placebo (experimental) and Sitagliptin + metformin + liraglutide placebo (experimental).

The registry classes the interventions as drug.

Who Took Part

407 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: \- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. \- Body mass index equal to or above 20 kg/m\^2.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: \- any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol; \- history of chronic pancreatitis or idiopathic acute pancreatitis; \- screening calcitonin value equal to or above 50 ng/l.

How the Study Was Run

Design: 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.

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 2013-12-02 with completion listed for 2015-06-15.

It ran at 106 sites in United States (58), Canada (17), Hungary (8), India (8), Israel (8) and Spain (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (Glycosylated Haemoglobin) (time frame: From baseline to week 26).

It also tracked 6 secondary outcomes, for example Change in Body Weight, Change in Fasting Plasma Glucose, Change in Fasting Blood Lipids, Change in Systolic Blood Pressure and Diastolic Blood Pressure and Number of Treatment Emergent Adverse Events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 407 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.