Adding Exenatide to Insulin Therapy for Patients With Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease

What Was Tested

The trial (phase 4) is built around Exenatide for fatty liver & elevated liver enzymes.

The primary aim of the study is to determine the impact on hepatic steatosis of replacing premeal rapid-acting insulin for exenatide (Byetta) while maintaining bedtime long-acting detemir (Levemir) insulin in well-controlled patients with type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD).

It had 1 arm (groups): Exenatide (twice daily) (experimental).

The registry classes the interventions as drug.

More on the Plan

Type 2 diabetes mellitus (T2DM) is a major public health problem in the United States with \~2/3 of Americans that are overweight or frankly obese.

Less well recognized is that obesity and T2DM are fueling another "silent epidemic": non-alcoholic fatty liver disease (NAFLD).

In NAFLD, hepatic fat accumulation ranges from simple steatosis to severe steatohepatitis (NASH), with necroinflammation and fibrosis that may progress to cirrhosis.

NASH is believed to be the most common cause of cryptogenic cirrhosis and ranking as the third leading indication for liver transplantation after alcohol and hepatitis C.

Who Took Part

The registry lists 24 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: Have been on intensified insulin therapy with insulin detemir (Levemir) and premeal insulin aspart (Novolog®) for the previous 6 months. Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent. Age range of 18 to 70 years (inclusive). All participants must have the following laboratory values:.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: past (within 1 year) or current history of alcohol abuse.

How the Study Was Run

It was run as a single-group and open-label study.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-01 with completion listed for 2009-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Hepatic Steatosis (time frame: 6 months).

It also tracked 7 secondary outcomes, for example A1c, Change in Anthropometric Variables (Weight), Insulin Secretion (Hyperglycemic Clamp), Percent Change From Baseline in Glucose Infusion (M Value) During Hyperglycemic Clamp, Lipid Profiles, Lipoprotein Analysis by NMR (LipoScience) and Change in Anthropometric Variables (BMI).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Exenatide in 24 people with fatty liver & elevated liver enzymes.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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