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

2016年11月18日 更新者：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.

調査の概要

状態

終了しました

条件

介入・治療

研究の種類

介入

入学 (実際)

31

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アルゼンチン
      • Correintes、アルゼンチン
        • GSK Investigational Site
      • Corrientes、アルゼンチン
        • GSK Investigational Site
      • Mendoza、アルゼンチン、5515
        • GSK Investigational Site
      • Mendoza、アルゼンチン、5539
        • GSK Investigational Site
      • Mendoza、アルゼンチン
        • GSK Investigational Site
      • Provincia de Buenos Aires、アルゼンチン、1754
        • GSK Investigational Site
      • Tucumán、アルゼンチン、T 4000IOE
        • GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：Metformin Small 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.
実験的：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.
薬：Metformin Large Pack
The large pack will consist of 1 month's supply of metformin.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in HbA1c Values at Week 28
時間枠：Baseline (Week 8) and 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

二次結果の測定

結果測定
メジャーの説明
時間枠
Mean Percent Compliance Throughout the Interventional Phase
時間枠：From Randomization to Week 28
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
時間枠：From enrollment to Week 8
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
時間枠：Week 28
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
時間枠：Week 28
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
時間枠：Week 28
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
時間枠：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 are presented.
Week 28
Number of Participants Who Missed Metformin Days/Doses for the Indicated Reasons
時間枠：Week 28
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
時間枠：Week 28
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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

GlaxoSmithKline

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年5月1日

一次修了 (実際)

2014年2月1日

研究の完了 (実際)

2014年2月1日

試験登録日

最初に提出

2013年3月21日

QC基準を満たした最初の提出物

2013年3月21日

最初の投稿 (見積もり)

2013年3月25日

学習記録の更新

投稿された最後の更新 (見積もり)

2017年1月9日

QC基準を満たした最後の更新が送信されました

2016年11月18日

最終確認日

2016年11月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 116086

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

試験データ・資料

  1. 注釈付き症例報告書
    情報識別子：116086
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. 臨床研究報告書
    情報識別子：116086
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. 個人参加者データセット
    情報識別子：116086
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. インフォームド コンセント フォーム
    情報識別子：116086
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. 研究プロトコル
    情報識別子：116086
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. データセット仕様
    情報識別子：116086
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  7. 統計分析計画
    情報識別子：116086
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

2型糖尿病の臨床試験

Metformin Small Packの臨床試験

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