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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01817777
• Other study ID #: 116086
• Status: Terminated
• Phase: Phase 4
• First received: March 21, 2013
• Last updated: September 25, 2014
• Start date: May 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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.
• Metformin Large Pack
The large pack will consist of 1 month's supply of metformin.

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Correintes
Argentina	GSK Investigational Site	Corrientes
Argentina	GSK Investigational Site	Mendoza
Argentina	GSK Investigational Site	Mendoza
Argentina	GSK Investigational Site	Mendoza
Argentina	GSK Investigational Site	Provincia de Buenos Aires
Argentina	GSK Investigational Site	Tucumán

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean Percent Compliance Throughout the Interventional Phase	Compliance for the study was estimated as a percentage, with the denominator defined as the number of pills dispensed by the pharmacist and the numerator defined as the number of pills taken, accounting for remaining pills at subsequent pharmacy visits.	From Randomization to Week 28	No
Secondary	Mean Percent Compliance Throughout the Observational Phase, Per Treatment They Were Randomized to in the Interventional Phase	Compliance was estimated during the 8-week Observational Phase for usual metformin treatment. During the Observational Phase, compliance was measured by monitoring the number of pill dispensed and the return of the pills or tablets.	From enrollment to Week 8	No
Secondary	Number of Participants Who Took Zero Metformin Pills for the Indicated Number of Days	The number of days on which no metformin pills were taken by participants was summarized.	Week 28	No
Secondary	Number of Participants With Diabetes Disease Management Modifications	Throughout the duration of the study, participants remained on their recommended metformin dosing regimens, unless a change in metformin dose was prescribed by their physician. The number of participants who received additional diabetes therapy for the management of diabetes was summarized.	Week 28	No
Secondary	Number of Participants Who Required a Non-routine Health Care Professional Visit for Diabetes	The number of participants who visited a health care professional for diabetes management during the study was summarized.	Week 28	No
Secondary	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 preferred their treatment regimens (interventional arm treatment [large or small pack metformin]) to how they previously took their medication are presented.	Week 28	No
Secondary	Number of Participants Who Missed Metformin Days/Doses for the Indicated Reasons	The number of particiapnts who missed days or doses of metformin was summarized.	Week 28	No
Secondary	Number of Participants Withdrawn From the Study Due to the Following Reasons: Withdrawal of Informed Consent; Lost to Follow-up	The number of participants who voluntarily discontinued participation in the study at any time or who were withdrawn by the investigator for pre-defined reasons was summarized.	Week 28	No