An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects

What Was Tested

The trial (phase 4) is built around Exenatide.

The primary objective of this study is to compare the effect of albiglutide and exenatide on gastric myoelectrical activity (GMA), gastric emptying (GE) and nausea (as measured by visual analogue scale \[VAS\]) in subjects with type 2 diabetes mellitus (T2DM).

The study is divided in two parts.

Part A will characterize the GMA, GE and nausea response to exenatide and confirm exenatide as a positive control for Part B.

It had three arms (groups): Part A: Exenatide (experimental), Part B: Albiglutide (experimental) and Part B: Exenatide (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 4 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Male or female, aged between 18 and 60 years of age at the time of signing the informed consent. Type 2 diabetes mellitus diagnosed at least 6 months prior to screening. Patient assessment of upper GI symptom severity index at screening:. Pre-menopausal with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; or documented bilateral oophorectomy, or;. Capable of giving signed informed consent; which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

The full record lists 12 inclusion and 28 exclusion criteria; among the exclusions: type 1 diabetes mellitus; type 2 diabetes mellitus treated with more than one oam or with chronic use of insulin within 3 months prior to screening; hemoglobinopathy that may affect proper interpretation of hba1c.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-09-26 with completion listed for 2017-03-16.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Part A: Distribution of Average Power by Frequency Region (time frame: Up to Day 4). Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region (time frame: Up to Day 4). Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal (time frame: Up to Day 4).

It also tracked 11 secondary outcomes, for example Part B: Time to Half-gastric Emptying, Part B: The Volume of Water Ingested During EGG, Part B: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score, Part B: Number of Par. With Abnormal Values for Vital Signs, Part B: Number of Par. With Abnormal Values for Hematology Parameters and Part B: Number of Par. With Abnormal Values for Clinical Chemistry Parameters.

What This Means in Plain Language

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

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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