Dose–response effects on HbA1c and bodyweight reduction of survodutide, a dual glucagon/GLP-1 receptor agonist, compared with placebo and open-label semaglutide in people with type 2 diabetes: a randomised clinical trial
An erratum to this article was published (Diabetologia, Apr 2024 ↗)
Authors' conclusion
Survodutide reduced HbA1c levels and bodyweight after 16 weeks' treatment in participants with type 2 diabetes. Dose-related gastrointestinal AEs could be mitigated with slower dose escalations.
Study context
- Population
- Adults aged 18–75 years with T2D, HbA1c 53–86 mmol/mol (7.0–10.0%) and BMI 25–50 kg/m² on background metformin411 in full analysis set
- Participants
- 413 adults
- Comparison
- Survodutide vs placebo and open-label semaglutide
- DG1n = 50
- DG2n = 50
- DG3n = 52
- DG4n = 50
- DG5n = 51
- DG6n = 50
- Semaglutiden = 50
- Placebon = 60reference
- Primary endpoint
- Absolute change from baseline in HbA1c
- Follow-up
- 16 weeks
Methodological detailsPhase II, multicentre, double-blind, parallel-group, placebo-controlled, semaglutide arm open-label
- Phase II
- Multicentre
- Double-blind
- Parallel-group
- Placebo-controlled
- Semaglutide arm open-label
Primary result
As reported in the abstract
Adjusted mean change from baseline in HbA1c
| Group | n | Value | % |
|---|---|---|---|
| DG1 | 41 | adjusted mean −9.92 (95% CI −12.27–-7.56) mmol/mol | −0.91% [−1.12, −0.69] |
| DG2 | 46 | adjusted mean −15.95 (95% CI −18.27–-13.63) mmol/mol | −1.46% [−1.67, −1.25] |
| DG3 | 36 | adjusted mean −18.72 (95% CI −21.15–-16.29) mmol/mol | −1.71% [−1.94, −1.49] |
| DG4 | 33 | adjusted mean −17.01 (95% CI −19.59–-14.43) mmol/mol | −1.56% [−1.79, −1.32] |
| DG5 | 44 | adjusted mean −17.84 (95% CI −20.18–-15.51) mmol/mol | −1.63% [−1.85, −1.42] |
| DG6 | 36 | adjusted mean −18.38 (95% CI −20.90–-15.87) mmol/mol | −1.68% [−1.91, −1.45] |
| Semaglutide | 45 | mean −16.07 mmol/mol | −1.47% |
n
DG141
DG246
DG336
DG433
DG544
DG636
Semaglutide45
Value
DG1adjusted mean −9.92 (95% CI −12.27–-7.56) mmol/mol
DG2adjusted mean −15.95 (95% CI −18.27–-13.63) mmol/mol
DG3adjusted mean −18.72 (95% CI −21.15–-16.29) mmol/mol
DG4adjusted mean −17.01 (95% CI −19.59–-14.43) mmol/mol
DG5adjusted mean −17.84 (95% CI −20.18–-15.51) mmol/mol
DG6adjusted mean −18.38 (95% CI −20.90–-15.87) mmol/mol
Semaglutidemean −16.07 mmol/mol
%
DG1−0.91% [−1.12, −0.69]
DG2−1.46% [−1.67, −1.25]
DG3−1.71% [−1.94, −1.49]
DG4−1.56% [−1.79, −1.32]
DG5−1.63% [−1.85, −1.42]
DG6−1.68% [−1.91, −1.45]
Semaglutide−1.47%
Secondary outcomes
| Outcome | DG6 | Semaglutide |
|---|---|---|
| Relative change from baseline in bodyweight (key secondary) · 16 weeks | mean −8.7% (95% CI −10.1–-7.3) · n = 37 | −5.3% (95% CI −6.6–-4.1) · n = 45 |
Relative change from baseline in bodyweight (key secondary) · 16 weeks
- Bodyweight decreased dose-dependently; survodutide ≥1.8 mg qw produced greater reductions than semaglutide
Safety
Adverse events
Adverse events
- Adverse events (AEs) with survodutide mainly gastrointestinal
Original publication
Dose–response effects on HbA1c and bodyweight reduction of survodutide, a dual glucagon/GLP-1 receptor agonist, compared with placebo and open-label semaglutide in people with type 2 diabetes: a randomised clinical trial. Diabetologia. Published 14 December 2023. doi:10.
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