An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: Metformin Small Pack (Drug); Metformin Large Pack (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change From Baseline in HbA1c Values at Week 28
Secondary outcome: Mean Percent Compliance Throughout the Interventional PhaseMean Percent Compliance Throughout the Observational Phase, Per Treatment They Were Randomized to in the Interventional Phase Number of Participants Who Took Zero Metformin Pills for the Indicated Number of Days Number of Participants With Diabetes Disease Management Modifications Number of Participants Who Required a Non-routine Health Care Professional Visit for Diabetes Number of Participants Who Preferred Their Treatment Regimens (Interventional Arm Treatment [Large or Small Pack Metformin]) to How They Previously Took Their Medication Number of Participants Who Missed Metformin Days/Doses for the Indicated Reasons Number of Participants Withdrawn From the Study Due to the Following Reasons: Withdrawal of Informed Consent; Lost to Follow-up
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Current use of any anti-diabetic medication other than metformin
Locations and Contacts
GSK Investigational Site, Correintes, Argentina
GSK Investigational Site, Corrientes, Argentina
GSK Investigational Site, Mendoza 5515, Argentina
GSK Investigational Site, Mendoza 5539, Argentina
GSK Investigational Site, Mendoza, Argentina
GSK Investigational Site, Provincia de Buenos Aires 1754, Argentina
GSK Investigational Site, Tucumán T 4000IOE, Argentina
Additional Information
Starting date: May 2013
Last updated: September 25, 2014
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