A Phase 4 interventional study of Metformin Small Pack and Metformin Large Pack in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Terminated at 7 sites in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-09.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and 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.
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This study's enrollment of 31 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
All 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.
Drug: Metformin Small Pack
All 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.
Drug: Metformin Large 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.
The large pack will consist of 1 month's supply of metformin.
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 28
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.
| Milestone | Routine Metformin | Small Pack Metformin | Large Pack Metformin |
|---|---|---|---|
| Started | 36 | 0 | 0 |
| Completed | 31 | 0 | 0 |
| Not completed | 5 | 0 | 0 |
| Withdrew: Lost to follow-up | 3 | 0 | 0 |
| Withdrew: Early study termination | 2 | 0 | 0 |
| Milestone | Routine Metformin | Small Pack Metformin | Large Pack Metformin |
|---|---|---|---|
| Started | 0 | 16 | 15 |
| Completed | 0 | 11 | 10 |
| Not completed | 0 | 5 | 5 |
| Withdrew: Withdrawal by subject | 0 | 3 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 2 |
| Withdrew: Early study termination | 0 | 1 | 3 |
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).
| Percentage | Small Pack Metformin | Large Pack Metformin |
|---|---|---|
| Change From Baseline in HbA1c Values at Week 28 | -0.026 ± 0.5511 | -0.109 ± 0.8631 |
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.
| Percent compliance | Small Pack Metformin | Large Pack Metformin |
|---|---|---|
| Mean Percent Compliance Throughout the Interventional Phase | 74.08 ± 11.439 | 90.83 ± 4.778 |
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.
| Percent compliance | Small Pack Metformin | Large Pack Metformin |
|---|---|---|
| Mean Percent Compliance Throughout the Observational Phase, Per Treatment They Were Randomized to in the Interventional Phase | 65.61 ± 13.901 | 88.07 ± 22.303 |
The number of days on which no metformin pills were taken by participants was summarized.
| Participants | Small Pack Metformin | Large Pack Metformin |
|---|---|---|
| 1 day | 2 | 1 |
| 2 days | 1 | 1 |
| 3 days | 0 | 0 |
| 4 days | 0 | 0 |
| 5 days | 0 | 1 |
| 6 days | 0 | 0 |
| 7 or more days | 4 | 2 |
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.
| Participants | Small Pack Metformin | Large Pack Metformin |
|---|---|---|
| Number of Participants With Diabetes Disease Management Modifications | 0 | 1 |
The number of participants who visited a health care professional for diabetes management during the study was summarized.
| Participants | Small Pack Metformin | Large Pack Metformin |
|---|---|---|
| Number of Participants Who Required a Non-routine Health Care Professional Visit for Diabetes | 5 | 6 |
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.
| Participants | Small Pack Metformin | Large Pack Metformin |
|---|---|---|
| Number of Participants Who Preferred Their Treatment Regimens (Interventional Arm Treatment [Large or Small Pack Metformin]) to How They Previously Took Their Medication | 8 | 8 |
The number of particiapnts who missed days or doses of metformin was summarized.
| Participants | Small Pack Metformin | Large Pack Metformin |
|---|---|---|
| Lost Medication | 0 | 0 |
| Forgetful | 3 | 5 |
| Other | 3 | 1 |
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.
| Participants | Small Pack Metformin | Large Pack Metformin |
|---|---|---|
| Number of Participants Withdrawn From the Study Due to the Following Reasons: Withdrawal of Informed Consent; Lost to Follow-up | 4 | 2 |
Collected over Serious adverse events (SAEs) and non-serious AEs were collected from the start of interventional study treatment (Week 8) until Week 28.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Small Pack Metformin | — | 0/16 (0%) | 5/16 (31.3%) |
| Large Pack Metformin | — | 0/14 (0%) | 2/14 (14.3%) |
| Event | Small Pack Metformin | Large Pack Metformin |
|---|---|---|
| ColdInfections and infestations | 2/16 | 0/14 |
| HypertensionVascular disorders | 0/16 | 1/14 |
| BronchospasmRespiratory, thoracic and mediastinal disorders | 0/16 | 1/14 |
| DizzinessNervous system disorders | 1/16 | 0/14 |
| CataractEye disorders | 1/16 | 0/14 |
| FallInjury, poisoning and procedural complications | 1/16 | 0/14 |
| Endocervical polypReproductive system and breast disorders | 1/16 | 0/14 |
| Age, Continuous(Years) | Small Pack Metformin | Large Pack Metformin | Total |
|---|---|---|---|
| Mean | 58.3 ± 12.01 | 56.3 ± 10.52 | 57.3 ± 11.17 |
| Gender(Participants) | Small Pack Metformin | Large Pack Metformin | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 9 | 8 | 17 |
| Race/Ethnicity, Customized(participants) | Small Pack Metformin | Large Pack Metformin | Total |
|---|---|---|---|
| Caucasic (White) | 16 | 15 | 31 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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