A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus® in Adult Chinese Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 536
- 试验地点
- 32
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®)
研究概览
简要总结
The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in insulin naïve adult Chinese participants with Type 2 Diabetes Mellitus (T2DM) on 2 or more oral antihyperglycemic medications (OAMs). Participants will continue their OAMs throughout the study.
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
- •Have T2DM based on the disease diagnostic criteria World Health Organization (WHO) classification.
- •Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to screening.
- •Have a HbA1c ≥7.0% and ≤11.0%.
- •Body mass index (BMI) ≤35 kilograms per meter squared.
排除标准
- •Have used insulin therapy (outside of pregnancy) anytime in the past 1 year, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks.
- •Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90 days.
- •Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening.
- •Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
- •Have had ≥2 emergency room visits or hospitalizations due to poor glucose control.
- •Have known hypersensitivity or allergy to Lantus® or its excipients.
- •Are receiving chronic systemic glucocorticoid therapy at pharmacological doses or have received such therapy within 4 weeks immediately preceding screening.
- •Have obvious signs or symptoms, or laboratory evidence, of liver disease.
- •Have one of the following concomitant diseases: significant cardiac or gastrointestinal disease.
- •Have a history of renal transplantation, are currently receiving renal dialysis or have a serum creatinine greater than 2.0 milligrams per deciliter.
- •Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
- •Participants with active cancer or personal history of cancer within the previous 5 years.
- •Are pregnant or intend to become pregnant during the course of the study.
- •Are women who are breastfeeding.
研究组 & 干预措施
LY2963016
Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the fasting blood glucose (FBG) ≤100 milligram per deciliter (mg/dL) (5.6 millimoles per litre [mmol/L]) while avoiding hypoglycemia. Participants were allowed to continue oral antihyperglycemic medication (OAM).
干预措施: LY2963016 (Drug)
Lantus®
Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM.
干预措施: Lantus® (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®)
时间窗: Baseline, Week 24
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated by mixed-effects model for repeated measures (MMRM) with baseline, insulin secretagogues at study entry, treatment, visit and treatment\*visit in the model.
次要结局
- Percentage of Participants With HbA1c ≤6.5% at Week 24(Week 24)
- Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year)(Baseline through 24 weeks)
- Percentage of Participants With HbA1c <7% at Week 24(Week 24)
- Basal Insulin Dose Units Per Day(At Week 24)
- Change From Baseline in Basal Insulin Dose Units Per Day(Baseline, Week 24)
- Change From Baseline in Glycemic Variability of Fasting Blood Glucose(Baseline, Week 24)
- Change From Baseline in Body Weight(Baseline, Week 24)
- Insulin Treatment Satisfaction Questionnaire (ITSQ)(At Week 24)
- Change From Baseline in HbA1c (Lantus® to LY2963016)(Baseline, Week 24)
- Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values(Baseline, Week 24)
- Number of Participants With Detectable Anti-Glargine Antibodies(Baseline through 24 weeks)