NCT02561078已完成3 期
Safety and Efficacy of Human Regular U-500 Insulin Administered by Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Subjects With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Parallel Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 54
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes mellitus.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes mellitus (T2DM).
- •Current TDD >200 but ≤600 units of non U-500R insulin (MDI or CSII) and/or U-500R by MDI with syringe and vial for ≥3 months at entry.
- •If TDD of U-500R and other insulins are combined, then insulin other than U-500R not to exceed 25% of TDD.
- •HbA1c ≥7.5% and ≤12.0%.
- •Body mass index ≥25 but ≤50 kilograms per meter squared.
- •Have a history of stable body weight.
- •Concomitant antihyperglycemic agent (AHA) therapy may include metformin (MET), dipeptidyl peptidase-4 inhibitors and/or pioglitazone.
- •Approximately 64 to 96 subjects using glucagon-like peptide-1 (GLP-1) receptor agonists or sodium-glucose cotransporter 2 (SGLT2) inhibitors will be enrolled in Study Group B.
排除标准
- •Diagnosed with type 1 diabetes mellitus (T1DM) or other types of diabetes apart from T2DM.
- •Have obvious clinical or radiographic signs or symptoms of liver disease (except nonalcoholic fatty liver disease), cirrhosis, acute or chronic hepatitis, or alanine aminotransferase (ALT/SGPT) and/or aspartate aminotransferase (AST/SGOT) levels ≥2.5X upper limit of normal (ULN), alkaline phosphatase ≥2X ULN or total bilirubin ≥2X ULN.
- •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 screening.
- •Have received U-500R insulin by CSII in the 3 months prior to screening.
- •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.
- •Are taking chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy.
- •Have an irregular sleep/wake cycle.
- •Have used any weight loss drugs in the 3 months prior to screening.
- •Have a history of bariatric surgery including Roux-en-Y gastric bypass surgery, gastric banding, and/or gastric sleeve.
- •Have a history of an active or untreated malignancy, or in remission from a clinically significant malignancy during the last 5 years before screening.
- •Significant hearing loss and/or vision impairment deemed by the investigator to interfere with the safe use of OmniPod U-500 system.
- •Have cardiac disease with functional status that is New York Heart Association (NYHA) Class III or IV per New York Heart Association Cardiac Disease Functional Classification or have congestive heart failure requiring pharmacologic treatment.
- •Are women breastfeeding or pregnant, or intend to become pregnant during the course of the study; are men who intend to impregnate their partners; or are sexually active of procreation potential not actively practicing birth control by a method determined by the investigator to be medically acceptable. Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
研究组 & 干预措施
Human regular U-500 insulin administered by CSII
Experimental
Human regular U-500 insulin administered by CSII and titrated based on blood glucose readings for 26 weeks with a 2-week MDI lead-in.
干预措施: Human regular U-500 insulin (CSII) (Drug)
Human regular U-500 insulin administered by MDI
Active Comparator
Human regular U-500 insulin administered subcutaneously (SC) by MDI three times a day and titrated based on blood glucose readings for 26 weeks.
干预措施: Human regular U-500 insulin (MDI) (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline, 26 Weeks
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction.
次要结局
- Percentage of Participants With HbA1c <7.5%(26 Weeks)
- Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values(Baseline, 26 Weeks)
- Change From Baseline in Total Daily Dose (TDD)(Baseline, 26 Weeks)
- Percentage of Participants With Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL)(26 Weeks)
- Rate of Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL)(Baseline to 26 Weeks)
- Change From Baseline in Body Weight(Baseline, 26 Weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline, 26 Weeks)
- Percentage of Participants With HbA1c <7.0%(26 Weeks)
研究者
研究点 (54)
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