A Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 399
- 试验地点
- 42
- 主要终点
- Change From Baseline in HbA1c
研究概览
简要总结
The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (OAM):
- •dipeptidyl peptidase-4 (DPP-4) inhibitors
- •sodium-glucose cotransporter (SGLT-2) inhibitors
- •biguanides
- •alpha-glucosidase inhibitors
- •sulfonlyureas
- •HbA1c value of 6.5% to 10%, inclusive
- •Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive
排除标准
- •Type 1 diabetes mellitus or latent autoimmune diabetes
- •Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
- •Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
- •Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
- •Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m2
- •Active or untreated malignancy
- •Chronic (>14 days) systemic glucocorticoid therapy
研究组 & 干预措施
LY3209590 Algorithm 1
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 milligram per deciliter (mg/dL).
干预措施: LY3209590 (Drug)
LY3209590 Algorithm 2
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL.
干预措施: LY3209590 (Drug)
Insulin Degludec
Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%.
干预措施: Insulin Degludec (Drug)
结局指标
主要结局
Change From Baseline in HbA1c
时间窗: Baseline, Week 32
HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Change from baseline in HbA1c was analysed by mixed model repeated measures (MMRM) including fixed effects of treatment, stratification factors (country, BMI group \[\> 30 or ≤ 30\], sulfonylureas use at study entry), visit and treatment by visit interaction and baseline HbA1c as the covariate.
次要结局
- Change From Baseline in HbA1c Compared to Insulin Degludec(Baseline, Week 32)
- Change From Baseline in Insulin Dose (LY3209590)(Week 1, Week 32)
- Change From Baseline in Body Weight(Baseline, Week 32)
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590(Week 32)
- Change From Baseline in Fasting Glucose(Baseline, Week 32)
- Change From Baseline in Insulin Dose (Insulin Degludec)(Baseline, Week 32)
- Rate of Total Documented Symptomatic Hypoglycemia(Baseline through week 32)