Bagsværd,
The submission is based on the results from the SUSTAIN FORTE trial, which included 961 people with type 2 diabetes in need of treatment intensification. In the trial, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c at week 40 compared to semaglutide 1.0 mg. In the trial, both doses of semaglutide appeared safe and well-tolerated. The most common adverse events were gastrointestinal, the vast majority were mild to moderate and diminished over time and were consistent with the GLP-1 receptor agonist class. Compared to semaglutide 1.0 mg, the gastrointestinal adverse events were similar for semaglutide 2.0 mg.
“Following the announcement of the headline results in November, we have expeditiously prepared the submission file. The submission in the EU represents an important milestone for people living with type 2 diabetes who have poor glycaemic control and need treatment intensification” said
About the SUSTAIN clinical programme
The SUSTAIN clinical development programme for once-weekly subcutaneous semaglutide injection currently comprises 11 phase 3 global clinical trials, including a cardiovascular outcomes trial, involving more than 11,000 adults with type 2 diabetes.
For more information about the SUSTAIN Forte trial, please read the headline results here
About
Further information
Media: | ||
Martin Havtorn Petersen | +45 3075 5246 | mhpz@novonordisk.com |
+1 609 240 9429 | kiau@novonordisk.com | |
Investors: | ||
Daniel Muusmann Bohsen | +45 3075 2175 | dabo@novonordisk.com |
+45 3079 0301 | jvls@novonordisk.com | |
Ann Søndermølle Rendbæk | +45 3075 2253 | arnd@novonordisk.com |
+45 3079 4211 | mjhr@novonordisk.com | |
+1 609 235 2989 | krdb@novonordisk.com |
Attachment
- PR201229_SUSTAIN_Forte_EU_submission
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