Study Stopped
It's no longer feasible to continue to recruit patients into the study as severe recruitment difficulties have been experienced since the study start
An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes
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
1 other identifier
interventional
31
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 diabetes-mellitus-type-2
Started May 2013
Shorter than P25 for phase_4 diabetes-mellitus-type-2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2013
CompletedFirst Posted
Study publicly available on registry
March 25, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
September 30, 2014
CompletedJanuary 9, 2017
November 1, 2016
9 months
March 21, 2013
September 25, 2014
November 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in HbA1c Values at 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).
Baseline (Week 8) and Week 28
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (2)
Metformin Small Pack Arm
EXPERIMENTALAll 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.
Metformin Large Pack Arm
EXPERIMENTALAll 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
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.
The large pack will consist of 1 month's supply of metformin.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current use of any anti-diabetic medication other than metformin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (7)
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
San Miguel de Tucumán, T 4000IOE, Argentina
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2013
First Posted
March 25, 2013
Study Start
May 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
January 9, 2017
Results First Posted
September 30, 2014
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.