Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function

What Was Tested

The trial (phase 4) is built around Liraglutide.

The purpose of this study is to investigate and evaluate the effects of liraglutide combined with short-term continuous subcutaneous insulin infusion(CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.

It had two arms (groups): CSII (active comparator) and Liraglutide (active comparator).

Continuous subcutaneous insulin infusion for 2-4 weeks.

The registry classes the interventions as drug.

More on the Plan

The purpose of this study is to investigate and evaluate the effects of liraglutide combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.liraglutide combined with CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.

Who Took Part

100 planned participants were the target.

It was open to people of any sex aged from 20 years up to 65 years.

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

Examples of who could join: Newly diagnosed type 2 diabetes. Body mass index (BMI) ranging from 21-35kg/m2. Antihypercaemic and antihyperlipidemic medication-naive patients.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: having any severe acute or chronic diabetic complications; renal dysfunction, blood creatinine\>150umol/l; blood aminotransferase level rising up(more than 2 times of the upper normal limit of alt).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

It started in 2013-02 with completion listed for 2014-12.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: the percentage of the patients who maintain glucose control 1 year after short intensive therapy (time frame: 1 year).

It also tracked 2 secondary outcomes, for example the acute insulin response reflected β-cell function of different interventions in newly-diagnosed type 2 diabetic patients and the remission rate differ from interventions in newly-diagnosed type 2 diabetic patients.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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