Once‑weekly IcoSema versus once‑weekly insulin icodec in type 2 diabetes management (COMBINE 1): an open‑label, multicentre, treat‑to‑target, randomised, phase 3a trial
Primary result · Change in HbA1cResult — go to the resultETD −0.66 percentage points 95% CI −0.76 to −0.57Authors' conclusion
In adults with inadequately controlled type 2 diabetes on daily basal insulin therapy, once-weekly IcoSema showed superiority to once-weekly icodec alone in changes in HbA1c and in overall lower rate of combined clinically significant or severe hypoglycaemia. IcoSema might provide an option for insulin therapy intensification in adults with type 2 diabetes.
Study context
- Population
- Adults ≥18 years, BMI ≤40 kg/m², T2D (HbA1c 7.0–10.0%) on daily basal insulin ± oral glucose-lowering drugs; 192 sites, 20 countries and regions; mean age 60.6 years, 62% malesrandomised 1:1
- Participants
- 1,291 adults
- Comparison
- Once-weekly IcoSema vs once-weekly icodec
- IcoSeman = 646
- Icodecn = 645reference
- Primary endpoint
- Change in HbA1c from baseline, full analysis set
- Follow-up
- Week 52
Methodological detailsopen-label, treat-to-target, multicentre, phase 3a, Enrolment June 1, 2022 – March 13, 2023; 1671 screened
- Open-label
- Treat-to-target
- Multicentre
- Phase 3a
- Enrolment June 1, 2022 – March 13, 2023; 1671 screened
Primary result
Change in HbA1c
ETD
−0.66 percentage points
95% CI −0.76 to −0.57
P < 0.0001
Change by group
IcoSema
−1.55
estimated mean change · SE 0.03 · percentage points
Icodec
−0.89
estimated mean change · SE 0.03 · percentage points
As reported in the abstract
Further findings
| Outcome | IcoSema | Icodec | Estimated rate ratio (95% CI) | P value | |
|---|---|---|---|---|---|
| Combined clinically significant or severe hypoglycaemia rate · baseline to week 57Superiority confirmed · episodes per person-year of exposure | 0.14 | 0.63 | 0.22 (0.14–0.36) | P < 0.0001 | |
| 0.10.31310Estimated rate ratio (log scale) |
Safety
Most frequent AEs (by system organ class)
Class IcoSema gastrointestinal disorders · Icodec infections and infestations
Participants analysed IcoSema 644 · Icodec 644
Events IcoSema 1033 · Icodec 466
Serious adverse events
- Serious adverse events — Treatment-related deaths
- 0
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →