NCT00551538已完成4 期
Twenty-Four-Hour Plasma Glucose Profiles Observed in Patients With Type 2 Diabetes During Therapy Consisting of Oral Agent(s) Plus Twice-Daily Insulin Lispro Low Mixture or Once-Daily Insulin Glargine
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
- 15
- 试验地点
- 1
- 主要终点
- Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period.
研究概览
简要总结
The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will result in lower post prandial blood glucose readings versus once-daily glargine plus oral diabetic medications.
详细描述
The primary objective of this study is to test the hypothesis that a twice daily insulin regimen consisting of insulin lispro (mix 75/25)plus OAMs will result in a lower 2 hour postprandial plasma glucose, averaged across the morning and evening meals, compared with once daily insulin glargine plus OAMs at bedtime following 12 weeks of treatment.
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
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes
- •Have inadequate overall glycemic control (hemoglobin A1c greater than or equal to 7.0% and less than or equal to 12.0%) at or within 4 weeks prior to Visit 1
- •Have used:
- •single or multiple OAMs for at least 3 months immediately prior to entering the study, including metformin, sulfonylurea, meglitinides (repaglinide, nateglinide), or alpha glucosidase inhibitors (acarbose, miglitol); or
- •insulin (once or twice daily) for at least 3 months immediately prior to entering the study; or
- •a combination of the above.
- •Are greater than or equal to 21 and less than 80 years of age
- •As determined by the investigator, are capable and willing to:
- •comply with their prescribed diet and medication regimen,
- •perform self blood glucose monitoring,
- •use the patient diary as required for this protocol,
- •participate in two 24 hour inpatient assessments
排除标准
- •Have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study
- •Are currently treated with a meglitinide without sulfonylurea
- •Have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin
- •Have plasma creatinine greater than or equal to 1.5 mg/dL (for males) or greater than or equal to 1.4 mg/dL (for females) for patients who will be treated with metformin or; greater than 2 mg/dL for patients treated with other OAMs, as determined by a local laboratory
- •Have received chronic (lasting longer than 2 weeks), systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 4 weeks immediately prior to Visit 1
研究组 & 干预措施
1
Active Comparator
Lispro mixture 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
干预措施: Lispro mix 75/25 (Drug)
2
Active Comparator
Glargine, once-daily, SC injection, given in conjunction with oral antidiabetic medications.
干预措施: Glargine (Drug)
结局指标
主要结局
Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period.
时间窗: At end of treatment arm or 3 months.
次要结局
- HbA1c(At end of treatment arm or 3 months.)
- 2 hour plasma glucose excursions, plasma glucose AUC, and plasma glucose AUC excursions after the three main test meals combined(At end of treatment arm or 3 months.)
- Plasma glucose AUC excursions during a 24 hours when plasma glucose exceeds the following: greater than or equal to 7.5 mmol/L (135 mg/dL), greater than or equal to 7.8 mmol/L (140 mg/dL), and greater than or equal to 10.0 mmol/L (180 mg/dL)(At end of treatment arm or 3 months.)
- Concentration of plasma triglycerides and free fatty acids(At end of treatment arm or 3 months.)
- The number of patients with increased plasma glucose during the last 2 hours of each inpatient period(At end of treatment arm or 3 months.)
- The mean amplitude of glycemic excursion(At end of treatment arm or 3 months.)
- Self blood glucose monitoring parameters: fasting, premeal, 2 hour postprandial, 2 hour postprandial excursion, bedtime, and overall daily blood glucose value(At end of treatment arm or 3 months.)
- Insulin dose and body weight(At end of treatment arm or 3 months.)
研究者
研究点 (1)
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