An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes
2016년 11월 18일 업데이트: GlaxoSmithKline
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.
연구 개요
연구 유형
중재적
등록 (실제)
31
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Correintes, 아르헨티나
- GSK Investigational Site
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Corrientes, 아르헨티나
- GSK Investigational Site
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Mendoza, 아르헨티나, 5515
- GSK Investigational Site
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Mendoza, 아르헨티나, 5539
- GSK Investigational Site
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Mendoza, 아르헨티나
- GSK Investigational Site
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Provincia de Buenos Aires, 아르헨티나, 1754
- GSK Investigational Site
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Tucumán, 아르헨티나, T 4000IOE
- GSK Investigational Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Metformin Small Pack Arm
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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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.
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실험적: Metformin Large Pack Arm
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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The large pack will consist of 1 month's supply of metformin.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in HbA1c Values at Week 28
기간: Baseline (Week 8) and Week 28
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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).
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Baseline (Week 8) and Week 28
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean Percent Compliance Throughout the Interventional Phase
기간: From Randomization to Week 28
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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.
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From Randomization to Week 28
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Mean Percent Compliance Throughout the Observational Phase, Per Treatment They Were Randomized to in the Interventional Phase
기간: From enrollment to Week 8
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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.
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From enrollment to Week 8
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Number of Participants Who Took Zero Metformin Pills for the Indicated Number of Days
기간: Week 28
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The number of days on which no metformin pills were taken by participants was summarized.
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Week 28
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Number of Participants With Diabetes Disease Management Modifications
기간: Week 28
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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.
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Week 28
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Number of Participants Who Required a Non-routine Health Care Professional Visit for Diabetes
기간: Week 28
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The number of participants who visited a health care professional for diabetes management during the study was summarized.
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Week 28
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Number of Participants Who Preferred Their Treatment Regimens (Interventional Arm Treatment [Large or Small Pack Metformin]) to How They Previously Took Their Medication
기간: Week 28
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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.
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Week 28
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Number of Participants Who Missed Metformin Days/Doses for the Indicated Reasons
기간: Week 28
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The number of particiapnts who missed days or doses of metformin was summarized.
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Week 28
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Number of Participants Withdrawn From the Study Due to the Following Reasons: Withdrawal of Informed Consent; Lost to Follow-up
기간: Week 28
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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.
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Week 28
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2013년 5월 1일
기본 완료 (실제)
2014년 2월 1일
연구 완료 (실제)
2014년 2월 1일
연구 등록 날짜
최초 제출
2013년 3월 21일
QC 기준을 충족하는 최초 제출
2013년 3월 21일
처음 게시됨 (추정)
2013년 3월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2017년 1월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 11월 18일
마지막으로 확인됨
2016년 11월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 116086
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
연구 데이터/문서
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주석이 달린 사례 보고서 양식
정보 식별자: 116086정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: 116086정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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개별 참가자 데이터 세트
정보 식별자: 116086정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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정보에 입각한 동의서
정보 식별자: 116086정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: 116086정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: 116086정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: 116086정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .