Clinical trial NCT01817777: An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Socioeconomic category
Medication compliance
Metformin
small pack
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-03-25
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in HbA1c Values at Week 28
timeFrame: Baseline (Week 8) and Week 28
Secondary outcomes:
measure: Mean Percent Compliance Throughout the Interventional Phase
timeFrame: From Randomization to Week 28
measure: Mean Percent Compliance Throughout the Observational Phase, Per Treatment They Were Randomized to in the Interventional Phase
timeFrame: From enrollment to Week 8
measure: Number of Participants Who Took Zero Metformin Pills for the Indicated Number of Days
timeFrame: Week 28
measure: Number of Participants With Diabetes Disease Management Modifications
timeFrame: Week 28
measure: Number of Participants Who Required a Non-routine Health Care Professional Visit for Diabetes
timeFrame: Week 28
measure: Number of Participants Who Preferred Their Treatment Regimens (Interventional Arm Treatment [Large or Small Pack Metformin]) to How They Previously Took Their Medication
timeFrame: Week 28
measure: Number of Participants Who Missed Metformin Days/Doses for the Indicated Reasons
timeFrame: Week 28
measure: Number of Participants Withdrawn From the Study Due to the Following Reasons: Withdrawal of Informed Consent; Lost to Follow-up
timeFrame: Week 28
Other outcomes:
Locations:
city: Correintes
country: Argentina
facility: GSK Investigational Site
city: Corrientes
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: Provincia de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Tucumán
country: Argentina
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: