BRIEF-Novo Nordisk Pioneer 8 Trial Of Oral Semaglutide Achieved Primary Objective

by Reuters
Friday, 26 October 2018 12:57 GMT

Oct 26 (Reuters) - NOVO NORDISK A/S PRESENTS RESULTS OF PIONEER 8 TRIAL:

* NOVO NORDISK TODAY ANNOUNCED THE HEADLINE RESULTS FROM PIONEER 8, A PHASE 3A TRIAL WITH ORAL SEMAGLUTIDE FOR THE TREATMENT OF ADULTS WITH TYPE 2 DIABETES

* ORAL SEMAGLUTIDE DEMONSTRATES STATISTICALLY SIGNIFICANT REDUCTIONS IN HBA1C AND BODY WEIGHT IN PEOPLE WITH LONG DURATION OF TYPE 2 DIABETES TREATED WITH INSULIN

* PIONEER 8 TRIAL ACHIEVED ITS PRIMARY OBJECTIVE BY DEMONSTRATING STATISTICALLY SIGNIFICANT AND SUPERIOR REDUCTIONS IN HBA(1C) AND BODY WEIGHT WITH ALL THREE DOSES OF ORAL SEMAGLUTIDE COMPARED TO PLACEBO

* WHEN APPLYING THE PRIMARY STATISTICAL APPROACH, THE TRIAL ACHIEVED ITS PRIMARY OBJECTIVE BY DEMONSTRATING STATISTICALLY SIGNIFICANT AND SUPERIOR REDUCTIONS IN HBA1C AND BODY WEIGHT WITH ALL THREE DOSES OF ORAL SEMAGLUTIDE COMPARED TO PLACEBO, ALL IN ADDITION TO INSULIN, AT WEEK 26

* WHEN APPLYING THE SECONDARY STATISTICAL APPROACH, FROM A MEAN BASELINE OF 8.2%, PEOPLE TREATED WITH 3, 7 AND 14 MG ORAL SEMAGLUTIDE ACHIEVED REDUCTIONS IN HBA1C OF 0.6%, 1.0% AND 1.4% RESPECTIVELY, COMPARED TO NO REDUCTION (0.0%) IN PEOPLE TREATED WITH PLACEBO, ALL IN ADDITION TO INSULIN, AT WEEK 26, AND 0.5%, 0.8% AND 1.2% RESPECTIVELY, COMPARED WITH 0.0% AT WEEK 52

* FROM A MEAN BASELINE BODY WEIGHT OF 85.9 KG, PEOPLE TREATED WITH 3, 7 AND 14 MG ORAL SEMAGLUTIDE EXPERIENCED A WEIGHT LOSS OF 1.0 KG, 2.9 KG AND 4.3 KG, RESPECTIVELY, COMPARED TO A WEIGHT INCREASE OF 0.6 KG IN PEOPLE TREATED WITH PLACEBO AT WEEK 52, ALL IN ADDITION TO INSULIN

* IN THE 52-WEEK TRIAL, PEOPLE TREATED WITH 3, 7 AND 14 MG ORAL SEMAGLUTIDE EXPERIENCED FEW AND COMPARABLE LEVELS OF SEVERE OR BLOOD GLUCOSE-CONFIRMED HYPOGLYCAEMIC EPISODES COMPARED TO PLACEBO

* ORAL SEMAGLUTIDE WAS WELL-TOLERATED AND WITH A PROFILE CONSISTENT WITH GLP-1-BASED THERAPY

* THE MOST COMMON ADVERSE EVENT FOR ORAL SEMAGLUTIDE WAS MILD TO MODERATE NAUSEA, WHICH DIMINISHED OVER TIME

* IN PIONEER 8, 11-23% OF PEOPLE TREATED WITH ORAL SEMAGLUTIDE EXPERIENCED NAUSEA, COMPARED TO 7% OF PEOPLE TREATED WITH PLACEBO

* THE PROPORTION OF PEOPLE WHO DISCONTINUED TREATMENT DUE TO ADVERSE EVENTS WAS 7-14% FOR PEOPLE TREATED WITH ORAL SEMAGLUTIDE COMPARED TO 3% WITH PLACEBO SOURCE TEXT FOR EIKON: FURTHER COMPANY COVERAGE: (Reporting by Jacob Gronholt-Pedersen)

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