Efficacy and safety of basal insulin degludec 100 IU/mL versus glargine 300 IU/mL for type 1 diabetes: The single-center INEOX randomized controlled trial
An erratum to this article was published (Diabetes Res Clin Pract, Apr 2024 ↗)
Authors' conclusion
Deg-100 and Gla-300 have similar metabolic efficacy, incidence ratio of nocturnal and severe hypoglycemia, DQOL and DTSQ scores. Differences in the incidence rate of hypoglycemia < 3.9 mmol/L and < 3.0 mmol/L should be confirmed.
Study context
- Population
- Adults with T1D on basal-bolus insulin therapy, HbA1c ≤ 10%, using SMBGrandomized 1:1
- Participants
- 129 vs 131
- Comparison
- Deg-100 vs Gla-300
- Deg-100n = 129
- Gla-300n = 131
- Primary endpoint
- Mean change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsopen-label, single-center, parallel-group, 24-week
- Open-label
- Single-center
- Parallel-group
- 24-week
Primary result
As reported in the abstract
Change in HbA1c
Deg-100
−0.07
± 0.7 · %
Gla-300
−0.16
± 0.77 · %
P = 0.320
Further findings
- No significant differences between groups in HbA1c, DQOL or DTSQ scores
Safety
Incidence rate of hypoglycemia < 3.9 mmol/L · during the study · main safety outcome
P < 0.001
Incidence rate of hypoglycemia < 3.0 mmol/L · during the study
P < 0.001
Nocturnal and severe hypoglycemia
- No significant differences between groups in nocturnal or severe hypoglycemia
Original publication
Efficacy and safety of basal insulin degludec 100 IU/mL versus glargine 300 IU/mL for type 1 diabetes: The single-center INEOX randomized controlled trial. Diabetes Res Clin Pract. Published 5 January 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →