Efficacy and safety of insulin glargine 300 U/ mL in people with type 2 diabetes in China: The INITIATION study
Authors' conclusion
Gla-300 was effective in improving glycaemic control and had a relatively low risk of hypoglycaemia in people with suboptimally controlled T2D who were insulin naïve or switching from another basal insulin in China.
Study context
- Population
- People with suboptimally controlled T2D in China, insulin naïve or switching from another basal insulin562 initiated Gla-300
- Participants
- 568 people
- Outcome
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsprospective, multicentre, phase IV
- Prospective
- Multicentre
- Phase IV
Main finding
As reported in the abstract
| Group | Value | Mmol/mol | P |
|---|---|---|---|
| Gla-300 | mean −0.91 (SE 0.05%) % | −9.9 ± 0.5 mmol/mol | P < .0001 |
Gla-300
Valuemean −0.91 (SE 0.05%) %
Mmol/mol−9.9 ± 0.5 mmol/mol
PP < .0001
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| Change in HbA1c from baseline, insulin-naïve subgroup · week 24 | Insulin-naïve mean −1.38 (SE 0.09%) % · mmol/mol −15.1 ± 1.0 mmol/mol |
| Change in HbA1c from baseline, insulin-experienced subgroup · week 24 | Insulin-experienced mean −0.68 (SE 0.05%) % · mmol/mol −7.4 ± 0.5 mmol/mol |
- Change in HbA1c from baseline, insulin-naïve subgroup: n = 189
- Change in HbA1c from baseline, insulin-naïve subgroup: P < .0001
- Change in HbA1c from baseline, insulin-experienced subgroup: n = 373
- Change in HbA1c from baseline, insulin-experienced subgroup: P < .0001
Safety
Confirmed hypoglycaemia (plasma glucose ≤ 3.9 mmol/L) · 24-week treatment period
- All hypoglycaemia, incidence
- 39.7%
- Nocturnal hypoglycaemia, incidence
- 13.3%
- Severe hypoglycaemia, incidence (low)
- 0.5%
Treatment-emergent adverse events (AEs) (treatment-emergent AEs (TEAEs))
- Participants with TEAEs
- 126 (22.4%)
- No serious treatment-related TEAEs
Original publication
Efficacy and safety of insulin glargine 300 U/ mL in people with type 2 diabetes in China: The INITIATION study. Diabetes Obes Metab. Published 29 July 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →