Bagsværd,
When evaluating the effects of treatment taken as intended1 and from a high mean baseline HbA1c of 8.9%, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c of 2.2% compared with a reduction of 1.9% with semaglutide 1.0 mg at week 40. The
From a mean baseline body weight of 99.3 kg, people treated with semaglutide 2.0 mg experienced a statistically significant1 and superior weight loss of 6.9 kg compared with 6.0 kg with semaglutide 1.0 mg.
When applying the treatment policy estimand2, people treated with semaglutide 2.0 mg experienced a reduction in HbA1c of 2.1% compared to 1.9% for people treated with 1.0 mg dose at week 40. People treated with semaglutide 2.0 mg experienced a statistically non-significant weight loss of 6.4 kg compared with 5.6 kg with semaglutide 1.0 mg.
Trial product estimand[1] | Treatment policy estimand2 | |||
Once-weekly semaglutide | 2.0 mg | 1.0 mg | 2.0 mg | 1.0 mg |
HbA1c reduction | 2.2%* | 1.9% | 2.1%* | 1.9% |
Body weight reduction | 6.9 kg* | 6.0 kg | 6.4 kg | 5.6 kg |
*Statistically significant vs once-weekly 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 with nausea rates around 15% for both doses. The treatment discontinuation rates due to adverse events were similar and below 5% for both doses of semaglutide.
“We are very pleased with the results from the SUSTAIN FORTE trial with the large HbA1c reduction from a high baseline as well as the safety and tolerability profile, which establish a attractive benefit-risk ratio for treatment of type 2 diabetes with semaglutide” 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 in total. Semaglutide 1.0 mg is approved under the brand name Ozempic® indicated for type 2 diabetes.
About
Further information
Media: | ||
+45 3079 8883 | mkd@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 |
Company announcement No 71 / 2020
1 Based on the trial product estimand: treatment effect if all people adhered to treatment and did not initiate other type 2 diabetes therapies
2 Based on the treatment policy estimand: treatment effect regardless of treatment adherence or initiation of other type 2 diabetes therapies
Attachment
- PR201117_SUSTAIN_FORTE
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