Last updated: 11/07/2018 10:06:00
An open study to evaluate whether pack size affects compliance of Metformin treatment in subjects with type II diabetes
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in HbA1c values at Week 28
Timeframe: Baseline (Week 8) and Week 28
Secondary outcomes:
Mean percent compliance throughout the Interventional Phase
Timeframe: From Randomization to Week 28
Mean percent compliance throughout the Observational Phase, per treatment they were randomized to in the Interventional Phase
Timeframe: From enrollment to Week 8
Number of participants who took zero metformin pills for the indicated number of days
Timeframe: Week 28
Number of participants with diabetes disease management modifications
Timeframe: Week 28
Number of participants who required a non-routine health care professional visit for diabetes
Timeframe: Week 28
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
Number of participants who missed metformin days/doses for the indicated reasons
Timeframe: Week 28
Number of participants withdrawn from the study due to the following reasons: withdrawal of informed consent; lost to follow-up
Timeframe: Week 28
Interventions:
Enrollment:
31
Primary completion date:
2014-28-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2
Product
metformin
Collaborators
Not applicable
Study date(s)
May 2013 to February 2014
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Males and females of age >=18 years
- Diagnosis of type II diabetes
- Current use of any anti-diabetic medication other than metformin
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Provincia de Buenos Aires, Argentina, 1754
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Other
Actual primary completion date
2014-28-02
Actual study completion date
2014-28-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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