A Pharmacy Based Open Study to Evaluate Whether Pack Size Affects Compliance for Subjects Diagnosed With Diabetes Type II Who Are Established on Metformin Treatment
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c Values at Week 28
研究概览
简要总结
MTF116086 is an open-label, randomised, parallel-design study in subjects with type II diabetes. The study is site-based, with local pharmacies serving as the sites and pharmacists as principal investigators for the sites. All subjects will enter an initial 8-week observational phase during which purchase behaviour and compliance with usual metformin use will be observed and recorded. At the end of the observational phase, subjects will be randomised to one of the two arms (metformin small pack vs. metformin large pack) for a 20-week interventional phase. The medication in the interventional phase is provided to the subjects free of charge. HbA1c will be collected for all subjects during Week 0, Week 8, and Week 28. Subjects will be asked questions about their tablet compliance, their satisfaction with the pack size they received and reasons for missing doses throughout the interventional phase by the pharmacist. The pharmacy visit on Week 28 will be end of the study.
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
- •Males and females of age >=18 years
- •Diagnosis of type II diabetes
- •HbA1c value no higher than 9.0%
- •Evidence of physician-supplied prescription for metformin use
- •Stable dose of metformin for 3 months prior to enrolment
- •Written informed consent from the subject
排除标准
- •Current use of any anti-diabetic medication other than metformin
研究组 & 干预措施
Metformin Small Pack Arm
All subjects in the study will be initially followed for an 8-week observational phase during which subjects will visit the pharmacy and purchase metformin following their usual routines. After 8-weeks subjects will be randomised to one of the 2 treatments arms. Subjects in the metformin small pack arm will receive medication free of charge in a small pack. Dosing of metformin will not be dictated by the protocol. Subjects will remain on their prescribed dose of metformin throughout the study, unless a change is recommended by their physician.
干预措施: Metformin Small Pack (Drug)
Metformin Large Pack Arm
All subjects in the study will be initially followed for an 8-week observational phase during which subjects will visit the pharmacy and purchase metformin following their usual routines. After 8-weeks subjects will be randomised to one of the 2 treatments arms. Subjects in the metformin large pack arm will receive medication free of charge in a large, monthly pack. Dosing of metformin will not be dictated by the protocol. Subjects will remain on their prescribed dose of metformin throughout the study, unless a change is recommended by their physician.
干预措施: Metformin Large Pack (Drug)
结局指标
主要结局
Change From Baseline in HbA1c Values at Week 28
时间窗: Baseline (Week 8) and Week 28
HbA1c was tested with a point-of-care device, which required a finger prick to obtain blood and provided an immediate result upon analysis in the device. HbA1c was tested at pharmacy visits corresponding to three time points: enrollment (Week 0), Baseline (Week 8), and End of Study (Week 28). The difference in the mean change from Baseline was to be calculated between the treatment arms (small pack minus large pack), and the 2-sided 95% confidence interval for the difference in mean change in HbA1c was to be calculated. However, because the study was terminated early, and the sample size was reduced, the statistical hypotheses defined in the protocol were not tested due to insufficient power. Therefore, the final analyses were limited to descriptive statistics. The percentage HbA1c is a measure of how much of the hemoglobin in the blood has become glycated (chemically bounded to glucose).
次要结局
- Number of Participants Withdrawn From the Study Due to the Following Reasons: Withdrawal of Informed Consent; Lost to Follow-up(Week 28)
- Mean Percent Compliance Throughout the Interventional Phase(From Randomization to Week 28)
- Mean Percent Compliance Throughout the Observational Phase, Per Treatment They Were Randomized to in the Interventional Phase(From enrollment to Week 8)
- Number of Participants Who Took Zero Metformin Pills for the Indicated Number of Days(Week 28)
- Number of Participants With Diabetes Disease Management Modifications(Week 28)
- Number of Participants Who Required a Non-routine Health Care Professional Visit for Diabetes(Week 28)
- Number of Participants Who Preferred Their Treatment Regimens (Interventional Arm Treatment [Large or Small Pack Metformin]) to How They Previously Took Their Medication(Week 28)
- Number of Participants Who Missed Metformin Days/Doses for the Indicated Reasons(Week 28)