Novel Approach for Basal Insulin Titration: A Proof-of-Concept Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Type 2 Diabetes Who Achieve Nadir Glucose in Range 70-125 milligram/deciliter (mg/dL)
研究概览
简要总结
The main purpose of this study is to evaluate a novel approach for insulin glargine (LY2963016) titration for insulin-naïve adults with type 2 diabetes (T2D)
The study will last about 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with type 2 diabetes as diagnosed by endocrinologist
- •No insulin over past 3 months
- •Inadequate glycemic control with A1c ≥8.0% at or within 1 month prior to screening visit
- •No history of diabetic ketoacidosis (DKA) or severe hypoglycemia leading to mental status change in the past 6 months
- •Willingness and ability to follow the protocol including willingness to commence basal insulin, wear CGM, and communicate with healthcare provider.
排除标准
- •Contraindication to use of insulin glargine (e.g., allergy)
- •Impaired recognition of hypoglycemia by the participant (as judged by the investigator)
研究组 & 干预措施
LY2963016
Participants with type 2 diabetes will be started on insulin glargine and dose will be titrated. Insulin glargine will be delivered via insulin pen each evening subcutaneously (SC). They will also check fasting blood glucose values on a study meter and prior to treating hypoglycemia. Participants will be asked to report the time and dose of their last administration.
干预措施: Basal Insulin (Drug)
结局指标
主要结局
Percentage of Participants with Type 2 Diabetes Who Achieve Nadir Glucose in Range 70-125 milligram/deciliter (mg/dL)
时间窗: Week 12
Percentage of participants with type 2 diabetes who achieve nadir glucose in range (70-125 mg/dl) over 15 consecutive minutes for ≥70% of days (typically 10 days) (last 14 days of active treatment)
次要结局
- Percentage of Participants with time in range (TIR) 70-180 mg/dl ≥70%(Week 12)
- Percentage of Participants with Hemoglobin A1c (HbA1c) at target (<7.0%)(Week 12)
- Percentage of Participants who successfully use Continuous Glucose Monitoring (CGM)(Week 12)