MAD, two period crossover study in type 2 diabetics
Research type
Research Study
Full title
A trial investigating the effect of oral semaglutide compared with placebo on postprandial glucose and triglyceride metabolism, energy intake, appetite sensations and gastric emptying in subjects with Type 2 diabetes
IRAS ID
201578
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2015-003998-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 9 days
Research summary
Oral semaglutide (“trial drug”) is an investigational drug which is being developed as a potential treatment for type 2 diabetes. \nType 2 diabetes is a condition in which the amount of glucose (sugar) in the blood is too high because the body cannot use it properly. The hormone insulin is needed to allow glucose to pass into the body cells to provide energy. Glucose comes from the digestion of starchy foods such as bread, rice, potatoes, from fruit, from some dairy products and from sugar and other sweet foods. Glucose is also stored and released from the liver. Type 2 diabetes develops when the body can still make some insulin, but not enough, or when the insulin that is produced does not work properly (known as insulin resistance).\nSemaglutide is a new medication that is comparable to and has a similar effect to a hormone already found in the body called GLP-1 (human glucagon-like peptide-1). Oral semaglutide stimulates insulin secretion in patients with high glucose levels and therefore helps glucose return to normal levels. The purpose of the present trial, is to test the effect of oral semaglutide 14 mg on fasting and postprandial (after a meal) glucose and triglyceride metabolism in subjects with T2D.\nMore than 1200 subjects have received oral semaglutide in previous clinical trials; the results from these studies suggest there are no anticipated safety issues with the dose levels to be given in this study.\nThis study will involve two treatment periods of 12 weeks duration each. In one treatment period subjects will receive the study drug while in the other they will receive placebo. \nSubject participation is expected to last up to 40 weeks from the time of screening till the last post-study visit. \n
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0074
Date of REC Opinion
3 May 2016
REC opinion
Further Information Favourable Opinion