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 this study is testing ClinicalTrials.gov NCT02793154 ↗

Description as written by the study sponsor.

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. Part B will compare the effects of albiglutide and exenatide on GMA, GE and nausea. Part A is a single arm, open-label design and all subjects will receive 10 microgram (mcg) subcutaneous exenatide twice daily for 5 days. This part will comprise 3 study periods: a 3-week screening/wash-out, 5-day treatment, and follow-up (within 7 days after the last dose of exenatide). The total duration of a subject's participation in Part A will be approximately 5 weeks. Once Part A is complete, data will be reviewed and a decision to progress to Part B will be made. In Part B, subjects will be randomized 1:1 to receive either albiglutide (starting dose of 30 milligrams \[mg\] once weekly for 4 weeks, followed by 50 mg once weekly for 4 weeks) or exenatide (starting dose of 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 4 weeks). The total duration of a subject's participation in the study will be approximately 15 weeks.

Treatments tested

• Exenatide also known as Byetta Drug

  Supplied as SC injection containing 250 mcg/mL of exenatide, provided in the following dose regimens: Part A: 10 mcg taken twice daily for 5 days; Part B: 5 mcg twice daily taken for 4 weeks followed by uptitration to 10 mcg for 4 weeks In both parts, it will be administered within 60-minute period before morning and evening meals (or before 2 meals with approximate \>=6 hours apart)

• Albiglutide also known as Tanzeum in US Drug

  Part B: Albiglutide will be supplied as follows:30 mg SC injection pen containing 40.3 mg lyophilized albiglutide and 0.65 mL; 50 mg SC injection pen contains 67 mg lyophilized albiglutide and 0.65 mL water; Starting dose will be 30 mg weekly for 4 weeks and then uptitrated to 50 mg weekly for 4 weeks; Administered as a single SC injection once a week in the morning