Continuous Glucose Monitoring-Based Titration of Once-Weekly Insulin Icodec in Insulin-Naive Individuals with Type 2 Diabetes (ONWARDS 9): A Phase 3b, Multicenter, Single-Arm, Treat-to-Target Clinical Trial
Authors' conclusion
After 26 weeks of treatment with icodec titrated based on CGM data, there was a statistically significant reduction in HbA1c from baseline, and the internationally recommended CGM targets for TIR, TAR >180 mg/dL, and TBR <54 mg/dL were achieved.
Study context
- Population
- Insulin-naive adults with T2D (HbA1c 7.0%-11.0%) using an intermittently scanned continuous glucose monitoring (CGM) device58 screened
- Participants
- 51 adults
- Outcome
- Change in HbA1c
- Follow-up
- Week 0 to week 26
Methodological detailsphase 3b, multicenter, treat-to-target
- Phase 3b
- Multicenter
- Treat-to-target
Main finding
As reported in the abstract
HbA1c, observed mean at week 0
8.18%
HbA1c, estimated mean at week 26
7.00%
Reduction in HbA1c (95% CI −1.36; −0.99), P < 0.0001
−1.17%-points
Further findings
Time in range (TIR) (70-180 mg/dL), exploratory · week −2 to 0 to week 22-26
- TIR increased
- 54.4% to 76.4%
Time above range (TAR) (>180 mg/dL), exploratory · week −2 to 0 to week 22-26
- TAR decreased
- 45.2% to 22.9%
Time below range (TBR) (<54 mg/dL), exploratory · week −2 to 0 to week 22-26
- TBR week −2 to 0
- 0.03%
- TBR week 22-26
- 0.04%
Safety
Hypoglycemia and safety · 26 weeks
- Severe hypoglycemic episodes
- 0
- No new safety concerns for icodec identified
Original publication
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