| Trial ID: | L7219 |
| Source ID: | NCT01817777
|
| Associated Drug: |
Metformin Small Pack
|
| Title: |
An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01817777/results
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| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Metformin Small Pack|DRUG: Metformin Large Pack
|
| Outcome Measures: |
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 | 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|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|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|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|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|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|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|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
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| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
31
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-05
|
| Completion Date: |
2014-02
|
| Results First Posted: |
2014-09-30
|
| Last Update Posted: |
2017-01-09
|
| Locations: |
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
|
| URL: |
https://clinicaltrials.gov/show/NCT01817777
|
