NCT00773279已完成3 期
A Multi-centre, Randomised, Open-label, Cross-over Study to Explore Effectiveness, Safety, and Preference of a New Disposable Pen PDS290 Versus FlexPen® in Subjects With Type 1 or Type 2 Diabetes
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 66
- 主要终点
- HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess and compare the effect on blood sugar control of insulin detemir and insulin aspart or insulin detemir alone administered by a insulin pen PDS290 (FlexTouch®) versus a Novo Nordisk marketed insulin pen (FlexPen®) in subjects with type 1 or type 2 diabetes mellitus. Furthermore, the subject's preference of the devices will be investigated by the use of questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Informed consent obtained before any trial-related activities
- •Subjects diagnosed with type 1 or type 2 diabetes. If type 2 diabetics, treatment with or without oral anti diabetic medication is allowed
- •Current users of vial/syringe (pen naïve) treated with short-acting insulin (insulin aspart, glulisine or lispro) and once daily long-acting insulin (detemir or glargine) or once daily long-acting insulin (detemir or glargine) alone
- •Treatment with insulin (i.e. aspart, glulisine, lispro, detemir or glargine) for at least 6 months
- •Body Mass Index (BMI) less than 45.0 kg/m^2
- •HbA1c less than or equal to 9.0% at screening visit based on analysis from central laboratory
- •Able and willing to adhere to the trial-specific insulin regimen for the entire trial period
排除标准
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or inadequate contraceptive techniques during the trial period (adequate contraceptive measures are considered as intrauterine device, oral contraceptives and barrier methods)
- •Previous participation in this trial (screening visit)
- •Systemic drugs that may influence glycaemic control (e.g., corticosteroids)
- •Known or suspected allergy to trial product(s) or related products
- •Known or suspected abuse of alcohol or drug abuse
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- •Previous treatment with sitagliptin
- •Clinically significant, active (or over the past 12 months) disease of the gastrointestinal, neurological, genitourinary, or haematological systems
- •Cardiac disease defined as: Decompensated heart failure (New York Heart class III or IV, unstable angina pectoris within the past 6 months of study enrolment, myocardial infarction within the past 12 months and a clinically significant history of arrhythmias or conduction delays on electrocardiogram (ECG) over the past 12 months
- •Any other severe acute or chronic illness as judged by the Investigator
- •Recurrent major hypoglycaemia (defined as severe central nervous system dysfunction associated with hypoglycaemia, requiring the assistance of another person) or hypoglycaemia unawareness (defined as a condition in which subjects no longer experience the usual warning signs of hypoglycaemia; the symptoms of hypoglycaemia may be different, less pronounced or even absent) or hospitalisation for diabetic ketoacidosis during the previous six months
- •Any other conditions that the Investigator judges would interfere with trial participation or evaluation of results (i.e. planned any diagnostic or therapeutic medical intervention such as surgery)
- •Participated in another clinical trial and received an investigational drug within the last 4 weeks
结局指标
主要结局
HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®
时间窗: Week 12 of each treatment sequence
次要结局
- Hypoglycaemic Episodes, Number of Events Per Subject Day(Weeks 0-12 (first treatment) and 12-24 (second treatment))
- Score for Treatment Impact Measure for Diabetes(Week 24)
- Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use(Week 24)
- Summary Score for Treatment Satisfaction(Week 24)
- Number of Hypoglycaemic Episodes(Weeks 0-12 (first treatment) and 12-24 (second treatment))
- Number of Adverse Device Effects(From randomisation (week 0) and until 7 days after Week 24 (Visit 16))
- Clinical Technical Complaints (CTCs)(Weeks 0-24 (whole trial period))
研究者
研究点 (66)
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