NCT00330473已完成3 期
A Phase 3, Open-Label, Parallel Group Treatment Concordance Study to Compare Insulin Use and Its Effect on Glycemic Control in Patients With Type 2 Diabetes Mellitus: Two Populations With Different Insulin Treatment Options
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
- 1,019
- 试验地点
- 1
- 主要终点
- To assess blood sugar control as measured by HbA1c
研究概览
简要总结
A study to compare insulin use and its effect on glucose control and other outcomes in patients with Type 2 diabetes who together with their healthcare provider manage their disease by discussing and agreeing on the diabetes treatment chosen from a selection of available treatment options.
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
- •Insulin-naive
- •Non-smoker
排除标准
- •Significant pulmonary, hepatic or renal disease
- •severe congestive heart failure
- •active malignancy or malignancy within the last 5 years
- •systemic glucocorticoid therapy
研究组 & 干预措施
1
Experimental
Treatment options available on the market plus the option of taking Human Insulin Inhalation Powder.
干预措施: Human Insulin Inhalation Powder (Drug)
2
Active Comparator
Treatment Options available on the market.
干预措施: Insulin (Drug)
结局指标
主要结局
To assess blood sugar control as measured by HbA1c
时间窗: baseline, 1,3,5,7,9 months
To assess acceptance of insulin therapy
时间窗: 9 months
次要结局
- To measure changes in HbA1c over time(baseline, 1,3,5,7,9 months)
- To assess safety by review of adverse events(throughout study)
- To assess patient-reported outcomes based on the W-BQ12 questionnaire(screening, baseline, months 5, and 9)
- To assess patient-reported outcomes based on the DTSQ Questionnaire(Screening,baseline, months 5 and 9)
- To assess patient-reported outcomes based on the DSC-R questionnaire(screening,baseline, months 5 and 9)
研究者
研究点 (1)
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