NCT02132637已完成3 期
A Comparison of Pharmacodynamics When Receiving a Double Dose of Insulin Peglispro or Insulin Glargine in Patients With Type 2 Diabetes Mellitus: A Double-Blind, Crossover Design Study
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
- 68
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Clinically Significant Hypoglycemia
研究概览
简要总结
The primary purpose of this study is to compare the effect of a double dose of a study drug known as insulin peglispro to a double dose of insulin glargine in participants who have type 2 diabetes. Participants will be treated with study insulin daily, in two 4-week study periods. Each participant will receive insulin peglispro during one treatment period and insulin glargine during the other treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes mellitus (T2DM), based on the World Health Organization (WHO) classification, for ≥1 year.
- •Use any type of basal insulin (except degludec), including once-or twice-daily human insulin neutral protamine Hagedom (NPH), insulin detemir, or insulin glargine.
- •Have hemoglobin A1c (HbA1c) levels ≤9.0% according to local laboratory testing at screening.
- •Have body mass index (BMI) ≤40.0 kilograms/square meter (kg/m^2).
- •Have been treated with stable doses of insulin for at least 30 days before screening with:
- •Basal insulin with daily doses ±30% of mean during the last 4 weeks.
- •Doses of a basal insulin must be between 0.3 unit/kg/day and 1 unit/kg/day.
- •If on metformin, thiazolidinediones (TZDs), sodium glucose co-transporter 2 (SGLT-2) inhibitors, or dipeptidyl peptidase (DPP4) inhibitors, must be on stable doses for the last 30 days.
排除标准
- •Are using prandial, self-mixed, or premixed insulin. Participants using prandial insulin may be switched to everyday (qd) glargine if investigator judges that the participant will still meet fasting glucose requirements for randomization.
- •Are using insulin pump therapy.
- •Have excessive insulin resistance: Defined as >1.0 unit/kg/day as baseline treatment.
- •If being treated with sulfonylureas (SUs) before screening, then must have SUs washed out between screening and randomization.
- •Use any of these concomitant medications: morphine, codeine, antidiuretics, glucagon-like peptide-1 (GLP-1) receptor agonists (for example, exenatide, exenatide once weekly, lixisenatide or liraglutide), or pramlintide, used concurrently or within 90 days before screening.
- •Have hypoglycemia unawareness, defined as confirmed by laboratory test results or by historical episodes of hypoglycemia <54 mg/dL (3.0 mmol/L) without symptoms.
- •Have fasting hypertriglyceridemia >400 mg/dL (>4.5 mmol/L) at screening, as determined by the local laboratory.
- •Have had any episode of severe hypoglycemia (defined by requiring assistance due to neurologically disabling hypoglycemia) within 6 months before entry into the study.
- •Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
- •Have had a previous clinically significant episode of ketoacidosis as determined by the investigator (ketone bodies at fasting and without acidosis is acceptable) in the past 6 months.
- •Have history of renal transplantation, are currently receiving renal dialysis, or have estimated Glomerular Filtration Rate (eGFR) <60 milliliters/minute.
- •Have obvious clinical signs or symptoms of liver disease (excluding nonalcoholic fatty liver disease), acute or chronic hepatitis, nonalcoholic steatohepatitis, or elevated liver enzyme measurements.
- •Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator.
研究组 & 干预措施
Insulin Peglispro
Experimental
Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
干预措施: Insulin Peglispro (Drug)
Insulin Glargine
Experimental
Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Percentage of Participants With Clinically Significant Hypoglycemia
时间窗: Predose to 84 Hours Post Double Dose
The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose \<54 milligrams per deciliter (mg/dL) (3.0 millimole per liter \[mmol/L\]) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100.
次要结局
- Nadir Glucose(Predose to 84 Hours Post Double Dose)
- Time to the Nadir Glucose(Predose to 84 Hours Post Double Dose)
- Duration of Glucose ≤70 mg/dL(Predose to 84 Hours Post Double Dose)
- Fasting Blood Glucose(Day 1, Day 2, and Day 3 Following Double Dose)
- Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC)(Preprandial to 3 Hours Postprandial during the day following the standard dose)
- Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion(Preprandial to 3 Hours Postprandial during the day following the standard dose)
- Beta Cell Function(0-30 minutes during the meal tolerance test on the day following the standard dose)
- Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose(Predose to 12 Hours Post Double Dose)
- Percentage of Participants With Hypoglycemia(Predose to 12 Hours Post Double Dose and 84 Hours Post Double Dose)
研究者
研究点 (2)
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