NCT01774968已完成4 期
Two Treatment Approaches for Human Regular U-500 Insulin (Thrice-Daily Versus Twice-Daily) in Subjects With Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on High-Dose U-100 Insulin Therapy With or Without Oral Agents: A Randomized, Open-Label, Parallel Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)
研究概览
简要总结
The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin three times a day versus twice a day.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes mellitus (World Health Organization [WHO] Classification of Diabetes)
- •Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m^2)
- •Have Glycated Hemoglobin A1c (HbA1c) ≥7.5% and ≤12.0%, as measured by the central laboratory at entry
- •Current U-100 insulin/analogue users on >200 and ≤600 units per day for ≥3 months at study entry and reconfirmed at randomization
- •Have a history of stable body weight for at least 3 months prior to study entry
- •Concomitant medications may include metformin (MET), dipeptidyl peptidase-4 (DPP-4) inhibitors approved for use with insulin at time of study entry (for example, sitagliptin, saxagliptin, and linagliptin), pioglitazone, and/or sulfonylureas (SUs)/glinides (repaglinide or nateglinide). Participant's oral antihyperglycemic drug (OAD) dose(s) must have been stable for ≥3 months
排除标准
- •Have type 1 diabetes mellitus or other types of diabetes mellitus apart from type 2 diabetes mellitus
- •Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase or aspartate aminotransferase levels ≥3 times the upper limit of the reference range
- •Have chronic kidney disease stage 4 and higher or history of renal transplantation
- •Have history of more than 1 episode of severe hypoglycemia within the 6 months prior to study entry
- •Have received insulin by continuous subcutaneous insulin infusion in the 3 months prior to study entry
- •Have received U-500R in the 3 months prior to study entry
- •Have had a blood transfusion or severe blood loss within 3 months prior to study entry or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia
- •Are taking chronic systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study entry
- •Have an irregular sleep/wake cycle
- •Have used rosiglitazone, once- or twice-daily glucagon-like peptide-1 (GLP-1) receptor agents, pramlintide, or other injectable or oral antihyperglycemic therapy not listed in the inclusion criteria in the 3 months prior to study entry. Participants may not have used once-weekly GLP-1 receptor agents in the 4 months prior to study entry
- •Have used any weight loss drugs in the 3 months prior to study entry
- •Have a history of bariatric surgery
- •Have a history of malignancy other than basal cell or squamous cell skin cancer
- •Have New York Heart Association (NYHA) Class III or IV per NYHA Cardiac Disease Functional Classification
- •Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable
研究组 & 干预措施
Human Regular U-500 Insulin TID
Experimental
Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.
干预措施: Human Regular U-500 Insulin (Drug)
Human Regular U-500 Insulin BID
Experimental
U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.
干预措施: Human Regular U-500 Insulin (Drug)
结局指标
主要结局
Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)
时间窗: Baseline, Week 24
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with investigator, baseline total daily dose (TDD; ≤300 or \>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.
次要结局
- Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24(Week 24)
- 30-Day Adjusted Rate of Hypoglycemic Events(Baseline through Week 24)
- Change From Baseline to Week 24 in Body Weight(Baseline, Week 24)
- Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin(Baseline, Week 24)
- Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin(Baseline, Week 24)
- Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels(Baseline, Week 24)
- Time to Reach HbA1c Target Values(Baseline through 6, 12, 18, and 24 weeks.)
- Percentage of Participants With Hypoglycemic Events(Baseline through Week 24)
- Change From Baseline to Week 24 in Number of Insulin Injections(Baseline, Week 24)
- Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG)(Baseline, Week 24)
- Change From Baseline to Week 24 in HbA1c Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg(Baseline, Week 24)
- Change From Baseline to Week 24 in 30-Day Adjusted Rate of Hypoglycemic Events Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg(Baseline, Week 24)
- Change From Baseline to Week 24 in Percentage of Participants With Hypoglycemic Events Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg(Baseline, Week 24)
- Change From Baseline to Week 24 in Body Weight Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg(Baseline, Week 24)
研究者
研究点 (1)
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