A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)
3期
已完成
NCT05514535
| 适应症 | Diabetes Mellitus, Type 2, Obesity |
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| 分期 | 3期 |
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| 申办方 | Novo Nordisk A/S |
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| 状态 | 已完成 |
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| 受试者人数 | 573 人 |
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| 干预（药物） | Semaglutide, Insuline glargine U100 (reduced), Insuline glargine U100 (titrated) |
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| 开始日期 | 2022年8月29日 |
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| 完成日期 | 2025年3月5日 |
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| 结果公布日 | 2026年5月11日 |
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摘要
This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dose of insulin glargine or a higher dose of insulin glargine. The study will last for about 47 weeks (approximately 11 months). Participants will have 9 clinic visits, 15 phone/video calls and 1 home visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 2 periods of 10 days during the study.
Change in Glycated Haemoglobin (HbA1c) [Noninferiority]
From baseline (week 0) to end of treatment (week 40) · Percentage point of HbA1c
| Insuline Glargine U100 (Reduced) + Semaglutide | -1.37 ± 0.84 Percentage point of HbA1c |
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| Insuline Glargine U100 (Titrated) | -0.65 ± 0.92 Percentage point of HbA1c |
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