Novo Nordisk successfully completes the first phase 3a trial, PIONEER 1, with oral semaglutide - Seite 2
"We are very encouraged by the results of the PIONEER 1 trial, which confirm the unprecedented oral efficacy of semaglutide that was reported in the phase 2 clinical trial in type 2 diabetes," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We look forward to providing data from the remaining nine PIONEER trials throughout this year and an expected regulatory submission in 2019."
About PIONEER 1 and the PIONEER clinical programme
PIONEER 1 was a 26-week, randomised, double-blinded, placebo-controlled, four-armed, parallel-group, multicentre, multinational trial comparing the efficacy and safety of three dose levels of
once-daily oral semaglutide vs placebo in people with type 2 diabetes treated with diet and exercise only. 703 people were enrolled in PIONEER 1 and randomised 1:1:1:1 to receive either a dose of
oral semaglutide (3, 7 or 14 mg) or placebo once daily. The primary endpoint was change in HbA1c from baseline at week
26.
The PIONEER phase 3a clinical development programme for oral semaglutide is a global development programme with an expected enrolment of more than 9,000 people with type 2 diabetes across 10 clinical trials, which all are expected to complete in 2018.
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Further information
Media: | ||
Katrine Sperling | +45 3079 6718 | krsp@novonordisk.com |
Ken Inchausti (US) | +1 609 786 8316 | kiau@novonordisk.com |
Investors: | ||
Peter Hugreffe Ankersen | +45 3075 9085 | phak@novonordisk.com |
Hanna Ögren | +45 3079 8519 | haoe@novonordisk.com |
Anders Mikkelsen | +45 3079 4461 | armk@novonordisk.com |
Christina Kjær | +45 3079 3009 | cnje@novonordisk.com |
Kasper Veje (US) | +1 609 235 8567 | kpvj@novonordisk.com |