Oral Semaglutide Dose Range in Type 2 (SNAC)
Research type
Research Study
Full title
Multiple dose trial examining dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes
IRAS ID
136719
Contact name
Melanie Davies
Contact email
Eudract number
2012-004994-16
ISRCTN Number
na
Clinicaltrials.gov Identifier
na
Research summary
The purpose of this trial is to compare the efficacy of various doses of oral semaglutide that has been formulated with a fixed dose of 300 mg SNAC (SNAC is an absorption enhancing component that will facilitate the transport of semaglutide from the gut into the blood stream). The trial has been designed to investigate a dose range that is expected to cover relevant therapeutic levels, reaching exposure levels that are equivalent to 0.5 and 1.0 mg of once-weekly subcutaneous (injected) semaglutide. Additional dose levels are also being examined to elucidate a wider dose-response spectrum below and above the expected therapeutic range.
The proposed study is a randomised, partially blind, dose range, dose escalation, multicentre trial including a total of 9 treatment arms. These are 7 oral semaglutide arms, an oral placebo arm and a subcutaneous semaglutide arm. All arms include type 2 diabetes patients that require treatment intensification.
Following confirmation of eligibility, patients will be randomised, in an equal manner, to the treatment arms. Treatment arms 1-8 will include once-daily dosing of a tablet and will be blinded. Treatment arm 9 features open-label, once-weekly subcutaneous injection. All arms include 26 weeks of treatment and a 5 week follow-up period. Oral dosing will be performed following specified fasting conditions.
For all groups the trial medication will be as an ’add-on’ to their previous metformin therapy or as monotherapy in the case where the subject is currently treated with diet and exercise alone.
It is planned that 1,005 patients will be screened in order to randomise 603. The trial will be carried out in Europe, North America and single countries in Africa, Asia and the Middle East and will include both genders. This population is expected to mimic the target population in both a future phase 3 programme and once marketed.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
13/EM/0325
Date of REC Opinion
28 Oct 2013
REC opinion
Further Information Favourable Opinion