Exenatide Compared With Insulin Glargine to Change Liver Fat Content in Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide and Insulin Glargine for fatty liver & elevated liver enzymes.

It had two arms (groups): Exenatide (experimental) and Insulin glargine (active comparator).

Insulin glargine subcutaneously, once daily, for 24 weeks.

The registry classes the interventions as drug.

More on the Plan

Patients should be on diet and exercise but drug treatment naive, no use of any glucagon-like peptide-1(GLP-1) analogues or insulin within 3 months before enrolment.Patients will have an screening period 2 weeks, and a 24-week open label treatment period.

All demographic data variables collected by descriptive analysis tests are used.

Qualitative variables use absolute frequency and percentage, and numeric variables use average, mean, median, standard deviation, maximum, minimum, quartiles, etc.

As supporting evidence, the analysis of primary endpoint variables must also comply with the Pre-protocol (PPS) Analysis.

Who Took Part

Enrollment: 76 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Male or female, 18 ≤ age ≤ 70 years old. Newly diagnosed type 2 diabetes mellitus (WHO Diagnostic criteria for diabetes mellitus, 1999). HBsAg (-), hepatitis C virus antibody (HCV-Ab) (-). BMI ≥ 24 kg/m2;.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: pregnancy, lactation, intended pregnancy, or failure to take adequate contraceptive measures taken (contraception measures including sterilization, intrauterine device, oral contraceptives, and persistent use of condoms); type 1 diabetes mellitus, gestational diabetes mellitus or other special types of diabetes; use of drugs that may affect liver fat content within one month before or during the trial period, such as glucocorticoids, thyroid hormone, etc.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Exenatide study: the fatty liver & elevated liver enzymes participants and staff both knew the treatment.

It started in 2015-03 with completion listed for 2017-11.

It ran at 5 sites in China (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in liver fat content（%） measured by MRS (time frame: baseline and 24 weeks).

It also tracked 4 secondary outcomes, for example Change in glucose metabolism (fasting blood glucose, postprandial plasma glucose, HbA1c), Change in blood lipid profile (total cholesterol, triglyceride, HDL, LDL) and Change in body weight,waist circumference and hip circumference.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Insulin Glargine in 76 people with fatty liver & elevated liver enzymes.

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

More context: the Exenatide compound page and the Insulin Glargine compound page, Fatty liver & elevated liver enzymes research.