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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01817777

Enrollment

Registered

2013-03-25

Start date

2013-05-31

Completion date

2014-02-28

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Socioeconomic category, Medication compliance, Metformin, small pack

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.

Interventions

DRUGMetformin 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.

DRUGMetformin Large Pack

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in HbA1c Values at Week 28	Baseline (Week 8) and 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).

Secondary

Measure	Time frame	Description
Mean Percent Compliance Throughout the Observational Phase, Per Treatment They Were Randomized to in the Interventional Phase	From enrollment to Week 8	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.
Number of Participants Who Took Zero Metformin Pills for the Indicated Number of Days	Week 28	The number of days on which no metformin pills were taken by participants was summarized.
Number of Participants With Diabetes Disease Management Modifications	Week 28	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.
Mean Percent Compliance Throughout the Interventional Phase	From Randomization to Week 28	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.
Number of Participants Who Preferred Their Treatment Regimens (Interventional Arm Treatment [Large or Small Pack Metformin]) to How They Previously Took Their Medication	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 are presented.
Number of Participants Who Missed Metformin Days/Doses for the Indicated Reasons	Week 28	The number of particiapnts who missed days or doses of metformin was summarized.
Number of Participants Withdrawn From the Study Due to the Following Reasons: Withdrawal of Informed Consent; Lost to Follow-up	Week 28	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.
Number of Participants Who Required a Non-routine Health Care Professional Visit for Diabetes	Week 28	The number of participants who visited a health care professional for diabetes management during the study was summarized.

Countries

Argentina

Participant flow

Recruitment details

Participants aged \>=18 years with a diagnosis of Type II diabetes mellitus (T2DM) and a glycated hemoglobin (HbA1c) value no higher than 9.0%; with evidence of a physician-supplied prescription for metformin use and on a stable dose of metformin for 3 months prior to enrollment; and on no anti-diabetic medication other than metformin were enrolled.

Pre-assignment details

Enrolled participants entered an 8-week Observational Phase (OP) prior to randomization to one of the treatment arms, followed by a 20-week Interventional Phase (IP). A total of 288 participants were planned; however, the study was prematurely discontinued when 36 participants had entered the OP. Of these 36, 31 had entered the IP.

Participants by arm

Arm	Count
Small Pack Metformin Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).	16
Large Pack Metformin Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month's supply of metformin.	15
Total	31

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Interventional Phase (20 Weeks)	Early Study Termination	0	1	3
Interventional Phase (20 Weeks)	Lost to Follow-up	0	1	2
Interventional Phase (20 Weeks)	Withdrawal by Subject	0	3	0
Observational Phase (8 Weeks)	Early Study Termination	2	0	0
Observational Phase (8 Weeks)	Lost to Follow-up	3	0	0

Baseline characteristics

Characteristic	Small Pack Metformin	Large Pack Metformin	Total
Age, Continuous	58.3 Years STANDARD_DEVIATION 12.01	56.3 Years STANDARD_DEVIATION 10.52	57.3 Years STANDARD_DEVIATION 11.17
Gender Female	7 Participants	7 Participants	14 Participants
Gender Male	9 Participants	8 Participants	17 Participants
Race/Ethnicity, Customized Caucasic (White)	16 participants	15 participants	31 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	5 / 16	2 / 14
serious Total, serious adverse events	0 / 16	0 / 14

Outcome results

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).

Time frame: Baseline (Week 8) and Week 28

Population: Per Protocol Population: all participants in the Intent-to-Treat Population (randomly assigned to treatment and who received \>= 1 dose \[or any portion of a dose\] of study medication and had an HbA1c test at Week 8) who did not have a protocol violation

Arm	Measure	Value (MEAN)	Dispersion
Small Pack Metformin	Change From Baseline in HbA1c Values at Week 28	-0.026 Percentage	Standard Deviation 0.5511
Large Pack Metformin	Change From Baseline in HbA1c Values at Week 28	-0.109 Percentage	Standard Deviation 0.8631

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.

Time frame: From Randomization to Week 28