A Comparison of Two Initial Dosing Formulas for Basal Insulin in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Days to reach the titration target
研究概览
简要总结
This study will evaluate two methods of starting basal insulin to see which method may achieve a faster-to-goal titration.
详细描述
The current recommended starting dose of basal insulin in type 2 diabetes is either a fixed dose, e.g. 10 U, or a weight-based formulas, 0.1-0.2 U/kg. The estimate of eventual titration dose to attempt to reach a fasting glucose goal is 0.49 U/kg. Those many weeks of dosage upward titration are required. The investigators propose to compare the current recommended weight based, 0.1 U/kg to a correction factor derived formula. Starting with an insulin tolerance test estimation of basal dose, one would arrive at the eventual titrated basal insulin dose in significantly less days than starting at a starting dose estimate of 0.1 U/kg. Further, there would be no significant increase in overall reported hypoglycemia.
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
- •Type 2 diabetes
- •Age 18 years and above
- •Concurrently on ± sulfonylureas ± thiazolidinedione ± DDP IV inhibitors ± metformin ± glinides
- •A1c ≥ 7.0% but ≤ 10%
- •Capable of self monitoring glucose ≥4/day
- •Previously compliant with clinical recommendations
- •Fasting blood glucose ≥ 150 mg/dl
- •BMI ≤ 45 kg/m2
排除标准
- •Urinary ketosis
- •Currently or expected alteration in insulin sensitivity such as major surgery, infection, renal failure (creatinine >1.5 mg/dl), glucocorticoid treatment, recent (within 2 weeks) serious hypoglycaemic episode (requires assistant of another)
- •Currently participating in another clinical trial
- •Known or suspected allergy to insulin determir
- •Using insulin
- •Pregnancy or nursing or the intention of becoming pregnant or not using adequate
- •Significant liver or heart failure.
研究组 & 干预措施
Insulin determir
干预措施: Insulin detemir (Drug)
结局指标
主要结局
Days to reach the titration target
时间窗: 12 weeks
The number of days for the subject to reach the titration target blood sugar of 110 ml/dl
次要结局
- The frequency of reported and documented (<70 mg/dl) hypoglycemic events per 24 hour period(12 weeks)
研究者
Allen B. King, MD
Principal Investigator
Diabetes Care Center