Comparison of Basal-bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes (PININ Study)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 72
- 主要终点
- Differences in mean daily blood glucose concentration
研究概览
简要总结
Pilot study to compare the efficacy and safety of a premixed-insulin regimen (70% intermediate insulin and 30% regular insulin) to a basal-bolus insulin regimen (glargine once daily and glulisine before meals) hospitalized patients with type 2 diabetes.
详细描述
Pilot, randomized, prospective, open-label study admitted to the Hospital with a previous diagnosis of type 2 diabetes or with a blood glucose level on admission greater than 180 mg/dl.
Patients were randomized to receive a premixed human insulin formulation with 70% intermediate insulin plus 30% regular insulin (Mixtard 30®, Novo Nordisk) or a basal-bolus regimen with glargine once daily and glulisine before meals (Lantus® and Apidra®, Sanofi-Aventis).
The primary outcome of the study was to determine differences in glycemic control between treatment groups as measured by mean daily blood glucose concentration during the hospital stay. Secondary objectives were to determine differences in the percentage of glucose measures between 80 and 180 mg/dl, frequency and severity of hypoglycemic events, total daily insulin use, length of hospital stay and glycemic viability between groups.
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
- •Previous diagnosis of type 2 diabetes with a blood glucose level on admission greater than 180 mg/dl and treated with diet, any combination of oral antidiabetics agents and/or insulin therapy
排除标准
- •Patients with hyperglycemia without a previous diagnosis of diabetes
- •Patients with acute hyperglycemic emergencies or with severe hyperglycemia treated with intravenous insulin infusion on admission
- •Patients with acute or chronic kidney disease (serum creatinine greater than 2 mg/dl),
- •Patients treated with corticosteroids
- •Patients with history of severe or repeated hypoglycemic episodes
- •Pregnant women
- •Patients expected to require ICU admission or less than 3 days of hospital stay
研究组 & 干预措施
Basal-bolus
'Lantus® once daily and Apidra® before meals
干预措施: Lantus® once daily and Apidra® before meals (Drug)
结局指标
主要结局
Differences in mean daily blood glucose concentration
时间窗: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks
Glucose concentration were measured in capillary blood 6 times a day, before and 2 hours after meals and daily mean calculated
次要结局
- Total daily Insulin use in International Units per Kg of weight(Participants will be followe for the duration of hospital stay, an expected average of 2 weeks)
- Number and severity of hypoglycemia episodes(Participants will be followe for the duration of hospital stay, an expected average of 2 weeks)
- Measures of dispersion of glycemia values (Glycemia variability)(Participants will be followe for the duration of hospital stay, an expected average of 2 weeks)