Conditions: Diabetes Mellitus, Type 2
Keywords: Socioeconomic category Medication compliance Metformin small pack
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Metformin Small Pack intervention 2: Metformin Large Pack
Intervention descriptions: intervention 1: A single small pack of metformin will consist of a blister package containing 10 pills with a patient information leaflet in local language. The small packs will be available at each site in the following doses: 500 mg, 850 mg, and 1000 mg. The small pack size of metformin is not yet marketed. Small pack metformin will be provided by GSK as GSK brand metformin. intervention 2: The large pack will consist of 1 month's supply of metformin.

Protocol document: