PIONEER 5 - Type 2 Diabetes with Moderate Renal Impairment
Research type
Research Study
Full title
Efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal impairment. A 26-week randomised, double-blind, placebo-controlled trial.
IRAS ID
208089
Contact name
Simon Heller
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2015-005326-19
Clinicaltrials.gov Identifier
U1111-1176-9230, Unique Trial Number (UTN)
Duration of Study in the UK
1 years, 4 months, 2 days
Research summary
NN9924-4234 is a randomised, double-blind placebo-controlled, multicentre, multinational study comparing the efficacy and safety of oral semaglutide with placebo in patients with type 2 diabetes and moderate renal impairment.
The study duration is approximately 33 weeks, consisting of a screening period of up to 2 weeks, a 26 week treatment period and a 5 week follow up period. If eligible, subjects will be randomised in a 1:1 manner to either 14mg oral semagluide once-daily or placebo once-daily (both as an add on to the subject's background treatment). There will be a 4 weekly dose escalation for subjects on oral semaglutide starting on a 3mg dose, followed by a 7mg dose then reaching the required 14mg dose for the duration of the treatment period.
The study consists of 8 clinic visits and a maximum of 6 phone contacts. The study plan is to include a total of 324 randomised subjects across 6 countries including the UK. The planned number of UK randomised subjects is 44 across a possible 8 sites.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0279
Date of REC Opinion
30 Aug 2016
REC opinion
Further Information Favourable Opinion