An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin Small Pack Arm

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.

Group Type EXPERIMENTAL

Metformin Small Pack

Intervention Type DRUG

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.

Metformin Large Pack Arm

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.

Group Type EXPERIMENTAL

Metformin Large Pack

Intervention Type DRUG

The large pack will consist of 1 month's supply of metformin.

Interventions

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Metformin Small Pack

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 Type DRUG

Metformin Large Pack

The large pack will consist of 1 month's supply of metformin.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Correintes, , Argentina

Site Status

GSK Investigational Site

Corrientes, , Argentina

Site Status

GSK Investigational Site

Mendoza, , Argentina

Site Status

GSK Investigational Site

Mendoza, , Argentina

Site Status

GSK Investigational Site

Mendoza, , Argentina

Site Status

GSK Investigational Site

Provincia de Buenos Aires, , Argentina

Site Status

GSK Investigational Site

San Miguel de Tucumán, , Argentina

Site Status

Countries

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Argentina

Study Documents

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