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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 Phase

Mean 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

Page last updated: August 23, 2015

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