C ontinuous glucose monitoring‐based time‐in‐range using insulin glargine 300 units/ ml versus insulin degludec 100 units/ ml in type 1 diabetes: The head‐to‐head randomized controlled InRange trial
Authors' conclusion
Using clinically relevant CGM metrics, InRange shows that Gla-300 is non-inferior to IDeg-100 in people with T1D, with comparable hypoglycaemia and safety profiles.
Study context
- Population
- Adults with T1D on MDI (basal insulin (BI) once daily and rapid-acting insulin analogues for ≥1 year), HbA1c ≥7% and ≤10% at screeningrandomized
- Participants
- 343 adults
- Comparison
- Insulin glargine 300 U/ml vs insulin degludec 100 U/ml
- Gla-300n = 172
- IDeg-100n = 171reference
- Primary endpoint
- Percentage TIR ≥70 to ≤180 mg/dl, by blinded 20-day CGM profiles
Methodological detailsmulticentre, active-controlled, parallel-group, open-label, non-inferiority (10% relative margin), 12-week
- Multicentre
- Active-controlled
- Parallel-group
- Open-label
- Non-inferiority (10% relative margin)
- 12-week
Primary result
Percentage TIR ≥70 to ≤180 mg/dl
Least squares (LS) mean difference (non-inferiority)
3.16%
95% CI 0.88%–5.44%
non-inferiority P = .0067
By group
Between Gla-300 and IDeg-100
LS mean difference (non-inferiority) 3.16% (95% CI 0.88%–5.44%); non-inferiority P = .0067
Non-inferiority margin 10 as printed, not drawn
As reported in the abstract
Secondary outcomes
LS mean
| Outcome | Gla-300 | IDeg-100 | LS mean difference (non-inferiority) (95% CI) | P value | |
|---|---|---|---|---|---|
| Glucose total CV (main secondary endpoint)Non-inferiority shown | 39.91% (95% CI 39.20%–40.61%) | 41.22% (95% CI 40.49%–41.95%) | −5.44% (−6.50% to −4.38%) | non-inferiority P < .0001 | |
| −10−505Difference (linear scale) |
Safety
Hypoglycaemia (self-measured and continuous glucose monitoring (CGM)-derived)
- Comparable between treatment groups
Safety
- Safety profiles consistent with known profiles, no unexpected findings
Original publication
C ontinuous glucose monitoring‐based time‐in‐range using insulin glargine 300 units/ ml versus insulin degludec 100 units/ ml in type 1 diabetes: The head‐to‐head randomized controlled InRange trial. Diabetes Obes Metab. Published 14 November 2022. doi:10.
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