Study to measure effect of MEDI0382 on liver glycogen in Type 2 DM

• Research type

  Research Study

• Full title

  An Exploratory Phase 2, Randomised, Double-blind, Placebo-controlled, and Open-label Active Comparator Study to Evaluate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects with Type 2 Diabetes Mellitus

• IRAS ID

  268998

• Contact name

  Carolyn Chee

• Contact email

  carolyn.chee@nuh.nhs.uk

• Sponsor organisation

  MedImmune Limited, a wholly owned subsidiary of AstraZeneca

• Eudract number

  2017-005081-22

• Duration of Study in the UK

  0 years, 6 months, 4 days

• Research summary

  Research Summary

  This research study will investigate the effects of a new medicine called MEDI0382 on liver glycogen (sugar stores) in overweight patients with type 2 diabetes that are treated with metformin. MEDI0382 has actions similar to two hormones – glucagon-like peptide 1 and glucagon. Glucagon is known to have effects on glycogen and fat levels in the liver therefore the aim of this study is to see if MEDI0382 causes changes in liver glycogen and fat.

  Approximately 30 patients will be randomized equally into 3 groups, to receive either MEDI0382 or placebo, or the comparator Liraglutide for 35 days. Participation in the study will last approximately 4 months, during which there will be 7 study visits, including a 60 day screening period, 35 day treatment period and a 28 day follow-up.

  Liver glycogen and fat levels will be measured before and after food, by Magnetic Resonance Spectroscopy to compare their levels before dosing and on the last day of dosing. The levels of glycogen and fat measured after treatment with MEDI0382 will be compared with those after treatment with placebo or comparator Liraglutide to assess how effective they are at reducing liver glycogen and fat.

  Summary of Results

  Lay summaries for parts A and B can be found on trialsummaries.com.
  https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbfpRKZVa7OWyQIFoKflfg1pt-2FHXflsiUe6hLYTyAdKtjGv2S-2Bdg0kVbENul2YSKV8wj6R9RfA6wGUPhKXNW7gk4qShT1r0f75E1lot7QjXDcPK3t_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLjSVOQuochy2qNoJSFt-2FIEeekV2lTvdfg4PrTCIyByfWjQbwDTaYzCfEv3oZoW-2FpP6TVKbCef2d4siQeR-2BCCnKHJrnAn74pWPUBHdN3NEu9hOslsMyqxLgVRg1qu-2BO1z4W6Q718nAd-2Fwfe9z-2FznMYwy0AHpd6NjGSSkU7zB84shb0e-2BDiS6kQDqNxpuInQtFg-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7Ce27a1387df8e446a7ac608da1c6369a0%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637853510535189545%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=iWy%2FhYGsm8X0XYLSI0evDnZqXUcV0N%2BmXyVxzCQp2gY%3D&reserved=0

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  19/EM/0308

• Date of REC Opinion

  18 Nov 2019

• REC opinion

  Further Information Favourable Opinion