A Prospective Randomized Trial to Compare Basal Bolus Therapies That Use Either Insulin Lispro Protamine Suspension or Insulin Glargine Together With Lispro Insulin in Patients With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24
研究概览
简要总结
This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).
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
- •Diabetes Mellitus, Type 2
- •Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
- •Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
- •Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m^2
- •Capable and willing to follow the protocol
- •Give written consent
排除标准
- •Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
- •Have a history of severe hypoglycemia in the past 6 months
- •Are pregnant or may become pregnant
- •Women who are breastfeeding
- •Have significant cardiac disease
- •Have significant renal or liver disease
- •Undergoing therapy for a malignancy
- •Contraindications to the study medications
- •Have an irregular sleep/wake cycle
- •Have a serious disease or any condition considered by the investigator to be exclusionary
研究组 & 干预措施
ILPS
Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections)
干预措施: Insulin Lispro (Drug)
Glargine
Glargine plus Insulin Lispro (2-3 injections)
干预措施: Insulin Glargine (Drug)
Glargine
Glargine plus Insulin Lispro (2-3 injections)
干预措施: Insulin Lispro (Drug)
ILPS
Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections)
干预措施: Insulin Lispro Protamine Suspension (ILPS) (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24
时间窗: Baseline, Week 24
Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.
次要结局
- Number of Injections of Insulin at Week 24(Week 24)
- Number of Participants With Adverse Events (AE)(Baseline through Week 24)
- Change in Body Weight From Baseline to Week 24(Baseline, Week 24)
- Change From Baseline in HbA1c at Week 12 and Week 24(Baseline, Week 12, Week 24)
- 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint(24 weeks)
- Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint(Week 24)
- Glycemic Variability at Endpoint(Week 24)
- Total Daily Insulin Dose at Endpoint(Week 24)
- Rate Of All Self-reported Hypoglycemic Episodes(Baseline through Week 24)
- Percentage of Participants With Self-Reported Hypoglycemic Episodes(Baseline through Week 24)