An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes
Status:
Terminated
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
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.