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It's no longer feasible to continue to recruit patients into the study as severe recruitment difficulties have been experienced since the study start
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin Small Pack Arm | Experimental | 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. |
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| Metformin Large Pack Arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin Small Pack | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Correintes | Argentina | ||||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 116086 | Annotated Case Report Form | View IPD |
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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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Routine Metformin | Participants were followed during an 8-week Observational Phase. During this phase, participants visited the pharmacy and purchased metformin (MTF) as per their usual routines. |
| FG001 | Small Pack Metformin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Observational Phase (8 Weeks) |
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| Metformin Large Pack | Drug | The large pack will consist of 1 month's supply of metformin. |
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| 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 |
| 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 | San Miguel de Tucumán | T 4000IOE | Argentina |
For additional information about this study please refer to the GSK Clinical Study Register |
| 116086 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116086 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116086 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116086 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116086 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116086 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
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).
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Interventional Phase (20 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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 | Posted | Mean | Standard Deviation | Percentage | Baseline (Week 8) and Week 28 |
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| 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. | Per Protocol Population | Posted | Mean | Standard Deviation | Percent compliance | From Randomization to Week 28 |
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| 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. | Per Protocol Population | Posted | Mean | Standard Deviation | Percent compliance | From enrollment to Week 8 |
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| 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. | Per Protocol Population | Posted | Number | Participants | Week 28 |
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| 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. | Per Protocol Population | Posted | Number | Participants | Week 28 |
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| 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. | Per Protocol Population | Posted | Number | Participants | Week 28 |
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| 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. | Per Protocol Population | Posted | Number | Participants | Week 28 |
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| 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. | Per Protocol Population | Posted | Number | Participants | Week 28 |
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| 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. | Observational Population: all participants enrolled into the study. If an enrolled participant withdrew from the study prior to the Week 8 visit, all available data on the participant was included in the Observational Population. | Posted | Number | Participants | Week 28 |
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Serious adverse events (SAEs) and non-serious AEs were collected from the start of interventional study treatment (Week 8) until Week 28.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received >=1 dose of study medication. Data were analyzed according to the actual treatment the participant received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 16 | 5 | 16 | ||
| EG001 | 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. | 0 | 14 | 2 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Cold | Infections and infestations | MedDRA | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Endocervical polyp | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Early Study Termination |
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