NCT00687453终止4 期
The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects on Combination Insulin-Oral Agent Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c Change From Baseline
研究概览
简要总结
To compare the efficacy and safety of once-nightly insulin glargine versus twice-daily NPH insulin in ethnic minority type 2 diabetic patients inadequately treated with once-nightly NPH insulin alone.
详细描述
Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when compared to twice-daily NPH insulin is not known when used in low-income ethnic minority patients. This study investigates whether insulin glargine may be more or less effective and safe than twice-daily NPH insulin in this population.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18-75
- •Type 2 diabetes diagnosed for at least 1 year
- •Inadequate glycemic control (hemoglobin A1c ≥ 7.5%) on stable and maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione, plus a single bedtime injection of NPH insulin
- •Except for the subject's current bedtime NPH insulin, no other past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)
- •Average fasting plasma glucose level <130 mg/dL without fasting hypoglycemia
- •Hemoglobin A1c between 7.5% and 12%
- •Body mass index (BMI) between 20 and 40 kg/m2
排除标准
- •History of confirmed (or clinical suspicion of ) type 1 diabetes
- •Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception.
- •Current pregnancy or lactation.
- •Subjects for whom intensive insulin therapy is contraindicated
- •Subjects with advanced proliferative diabetic retinopathy
- •Subjects who are unable to stay on a consistent daily meal schedule
- •History of any clinically significant renal, hepatic, cardiovascular, neurological, endocrinological or other major systemic disease that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the data difficult.
- •Subjects who will likely require or initiate therapy with drugs which may interfere with glucose metabolism during the course of the study
- •Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
- •Subjects who are unable or unwilling to comply with all components of the study protocol, including contacting the investigators at specified times and attending all scheduled follow-up visits.
研究组 & 干预措施
Insulin glargine injected at bedtime
Experimental
Insulin glargine injected at bedtime
干预措施: Insulin glargine at bedtime instead of NPH (Drug)
NPH insulin injected twice-daily
Active Comparator
NPH insulin injected twice-daily, before breakfast and at bedtime
干预措施: NPH twice-daily (Drug)
结局指标
主要结局
Hemoglobin A1c Change From Baseline
时间窗: Baseline to 6 months
次要结局
- Body Mass Index Change From Baseline(Baseline and 6 months)
- Frequency of Pre-supper Glucose Readings 130 mg/dL or Less, Change From Baseline(6 months)
- Frequency of Total Hypoglycemic Reactions(6 months)
- Frequency of Severe Hypoglycemic Reactions(6 months)
- Total Daily Insulin Dose(Baseline and 6 months)
- Any Adverse Event Other Than Hypoglycemia(6 months)
研究者
研究点 (1)
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