Effects of Nasulin v.Placebo on Blood Glucose Control in Patients With Type 2 DM Treated With Basal Insulin & Oral Antidiabetic Meds, Excluding Secretagogues in Phase 2A, Randomized, Parallel, Double-Blind, Placebo-Controlled, Multi-Center Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 21
- 主要终点
- Continuous Glucose Monitoring (CGM)
研究概览
简要总结
The purpose of this study is:
- To assess the efficacy of Nasulin vs. placebo as indicated by time spent in euglycemia, assessed by continuous glucose monitoring data and serum fructosamine levels in patient volunteers with Type 2 Diabetes.
- To asses the safety and tolerability of Nauslin at 50 IU and 100IU doses in patient volunteers with Type 2 Diabetes
详细描述
This proof of concept trial has a randomized, parallel, double-blind, placebo-controlled design with a 4-week single-blind placebo and diet run-in period. Given a ratio of 1:1, patient volunteers will be randomized into one of two parallel treatment arms, Nasulin in a combination with insulin glargine or placebo in combination with insulin glargine. The randomization period will be 6 weeks in length. The total length of individual patient volunteer participation, including screening and follow-up will be approximately 13-14 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with Type 2 diabetes (18 years of age or older)
- •Currently treated with basal insulin and OAD(s)
- •HbA1c range of 6.5 -
- •BMI less than 41
排除标准
- •Multiple daily injections of mealtime insulin
- •Regular use of nasal sprays
- •Significant nasal pathology
- •Employed in a job which required irregular shift or night work
研究组 & 干预措施
Placebo for Nasulin
Placebo for Nasulin Spray
干预措施: Placebo for Nasulin (Other)
Nasulin
Nasulin (intranasal insulin spray 1%)
干预措施: Nasulin (Drug)
结局指标
主要结局
Continuous Glucose Monitoring (CGM)
时间窗: Baseline and 5-6 weeks
Continuous glucose monitoring (CGM) data from patients receiving either Nasulin or placebo were collected and compared at baseline and the last two weeks of the study, and changes (week 5-6 minus baseline) in the mean percentage of time spend in euglycemia (70 to 180 mg/dl blood glucose) (MPTEU) were assessed from baseline Week 0 to Week 5-6.
次要结局
- Overall Glycemic Control(5-6 weeks)