Pharmacoscintigraphic investigation of a GLP-1 analogue (QBR110526)
Research type
Research Study
Full title
Pharmacoscintigraphic investigation of a long acting oral GLP-1 analogue in healthy male subjects.
IRAS ID
104308
Contact name
Joanne Collier
Sponsor organisation
Novo Nordisk
Eudract number
2011-004162-14
ISRCTN Number
n.a
Clinicaltrials.gov Identifier
n.a
Research summary
The Sponsor is developing a tablet form of the study drug, semaglutide. Semaglutide is also being developed for the treatment of Type 2 diabetes by injection under the skin. The purpose of the study is to see how a radiolabelled tablet form of the study drug, semaglutide, is broken down and taken up by the body when given with two different volumes of water and to compare where in the stomach or gut the tablet is broken down and how this affects how the semaglutide is taken up into the body. Blood samples will be taken to show how much of the semaglutide has been taken up by the body and images of the stomach and gut will be taken to show where the tablet breaks down. Diabetes is a disease that occurs due to a lower than normal action of the hormone insulin. Insulin is normally produced after eating a meal and its action in the body means that the sugar absorbed from the meal can be taken up from the bloodstream into the body's cells. In diabetes people can get high blood sugar levels because their body is not producing enough insulin (type 1 diabetes) or because there is a decreased effect of insulin on the tissues (type 2 diabetes). There already are several oral anti-diabetic drugs available. However, a large proportion of people with type 2 diabetes do not achieve the optimum blood sugar levels and there is still a need for alternative treatments. Therefore, in addition to semaglutide for injection, semaglutide is also being developed for dosing by mouth.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
12/EE/0181
Date of REC Opinion
30 May 2012
REC opinion
Further Information Favourable Opinion