Effectiveness and Safety of Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Chinese Adults With Type 2 Diabetes Mellitus: a Multicenter, Prospective Real-world Study (COLOR-REAL)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 594
- 试验地点
- 7
- 主要终点
- Change in HbA1c
研究概览
简要总结
This study is a multicenter, prospective, non-interventional real-world study to evaluate the clinical outcomes of biweekly cofrogliptin versus daily linagliptin as an add-on therapy in Chinese adult T2D patients.
详细描述
About 43 hospitals from different parts of China will take part in this study. Patients aged ≥18 years who have been previously treated with a stable dose of insulin and no more than three classes of oral antidiabetic drugs (OADs) for at least 12 weeks without adequate glycemic control will be enrolled and assigned to either cofrogliptin once every 2 weeks cohort or linagliptin once-daily cohort based on the prescription. Initiation of cofrogliptin or linagliptin treatment was at the treating physician's discretion.
Enrolled participants will undergo routine follow-up for up to 24 weeks. During the follow-up period, data will be collected from face-to-face participant-investigator visits at the beginning of the study (0 weeks, visit 1), early stage (4 weeks, visit 2), mid-stage (12 weeks, visit 3) and at the end of the study (24 weeks, visit 4). Data sources include patient medical records, diaries, self-monitoring of blood glucose (SMBG), and questionnaires. No additional diagnostics, monitoring procedures, or interventions outside of usual clinical practice will be applied to the participants. The project will probably last for about 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form.
- •Aged ≥18 years.
- •Diagnosed with type 2 diabetes mellitus (meeting the 1999 WHO diagnostic criteria).
- •Recently tested HbA1c 7%-9% and FPG ≤11 mmol/L, with stable treatment using insulin ± OADs for at least 12 weeks prior to enrollment. Insulin regimens are limited to: basal insulin once daily or once weekly, premixed insulin once or twice daily, or IDegAsp once or twice daily. OAD classes are limited to metformin, SGLT2 inhibitors, and α-glucosidase inhibitors and with no more than three agents in total.
- •Willing to start or have already initiated cofrogliptin or linagliptin treatment (at the physician's discretion in accordance with clinical practice). The treatment decision is independent of study enrollment, must be made before signing the informed consent, and cofrogliptin or linagliptin initiation must occur either within 2 weeks before or within 2 weeks after signing the informed consent.
排除标准
- •Allergic to the study drug.
- •Diagnosed with type 1 diabetes.
- •Unable to comply with study-specific procedures.
- •Current or planned pregnant, or currently breastfeeding.
- •With any other situation judged by the investigator, that is unsuitable for participation in this trial.
研究组 & 干预措施
Cofrogliptin cohort
干预措施: Cofrogliptin add to insulin (Drug)
Linagliptin cohort
干预措施: Linagliptin add to insulin (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: from baseline to 24 weeks
次要结局
- Change in HbA1c(from baseline to 12 weeks)
- Reaching of HbA1c target (defined as HbA1c less than 7%)(at 24 weeks)
- Change in FPG(from baseline to 24 weeks)
- Change in PPG(from baseline to 24 weeks)
- Change in fasting C peptide(from baseline to 24 weeks)
- Change in body weight(from baseline to 24 weeks)
- Change in insulin dose(from baseline to 24 weeks)
- Overall safety, consisting of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest(from baseline to 24 weeks)
研究者
Yanbing Li
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University