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Diabetes Mellitus, Type 2Phase 4NCT01817777

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

A Phase 4 study testing Metformin Small Pack and Metformin Large Pack in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 7 sites in Argentina.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Metformin Small Pack and Metformin Large Pack
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
7 sitesArgentina
Study dates
May 2013to Feb 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Current use of any anti-diabetic medication other than metformin

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Argentina7 sites

  • GSK Investigational Site

    Correintes

  • GSK Investigational Site

    Corrientes

  • GSK Investigational Site

    Mendoza, 5515

  • GSK Investigational Site

    Mendoza, 5539

  • GSK Investigational Site

    Mendoza

  • GSK Investigational Site

    Provincia de Buenos Aires, 1754

  • GSK Investigational Site

    San Miguel de Tucumán, T 4000IOE

Other trials in Argentina

About this study

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

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.

Being tested
Metformin Small Pack, Metformin Large Pack
Keywords
Socioeconomic category, Medication compliance, Metformin, small pack
Medical subject headings
Diabetes Mellitus, Type 2, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin Small PackDrug

    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 PackDrug

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

Study groups in NCT01817777
Study groupRoleWhat they receive
Metformin Small Pack ArmExperimentalAll 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.
Receives: Drug: Metformin Small Pack
Metformin Large Pack ArmExperimentalAll 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.
Receives: Drug: Metformin Large Pack

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline (Week 8) and Week 28

Secondary outcomes (8)

  1. 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.

    Measured: From Randomization to Week 28

  2. 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.

    Measured: From enrollment to Week 8

  3. 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.

    Measured: Week 28

  4. 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.

    Measured: Week 28

  5. 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.

    Measured: Week 28

  6. 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.

    Measured: Week 28

  7. 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.

    Measured: Week 28

  8. 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.

    Measured: Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Why it stopped: It's no longer feasible to continue to recruit patients into the study as severe recruitment difficulties have been experienced since the study start

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01817777
Sponsor's protocol ID
116086
Status last verified
Nov 2016
First submitted
21 Mar 2013
Last updated
9 Jan 2017
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin Small Pack and Metformin Large Pack in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 7 sites in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c Values at Week 28 (time frame: Baseline (Week 8) and Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01817777.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.

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Clinical Trial NCT01817777 | AzTrials