Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
2019年9月6日 更新者：Eli Lilly and Company
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.
This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes.
Patients will be treated for 24 months with a 2-month follow-up period.
調査の概要
研究の種類
介入
入学 (実際)
415
段階
- フェーズ 3
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
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California
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Sacramento、California、アメリカ、95825
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Santa Ana、California、アメリカ、92705
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Florida
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Jacksonville、Florida、アメリカ、32204
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Miami、Florida、アメリカ、33156
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Louisiana
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Baton Rouge、Louisiana、アメリカ、70808
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New Jersey
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Hamilton、New Jersey、アメリカ、08610
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South Carolina
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Greenville、South Carolina、アメリカ、29605
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Utah
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Ogden、Utah、アメリカ、84403
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West Virginia
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Charleston、West Virginia、アメリカ、25304
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Catania、イタリア、95100
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Genova、イタリア、16132
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Milano、イタリア、20132
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Pisa、イタリア、56100
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Rome、イタリア、00168
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Bangalore、インド、560010
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Mumbai、インド、400 007
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Pune、インド、411005
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Berlin、ドイツ、10115
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Dresden、ドイツ、01307
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Erlangen、ドイツ、91054
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Frankfurt、ドイツ、60596
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Leipzig、ドイツ、D-04103
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Mainz、ドイツ、D-55116
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Budapest、ハンガリー、H-1139
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Mako、ハンガリー、6900
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Veszprem、ハンガリー、8200
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Zalaegerszeg、ハンガリー、8900
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Fortaleza、ブラジル、60120-020
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Porto Alegre、ブラジル、90035-003
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São Paulo、ブラジル、04020041
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Manatí、プエルトリコ、00674
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San Juan、プエルトリコ、00907
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Yabucoa、プエルトリコ、00767
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Coimbra、ポルトガル、3000-076
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Lisbon、ポルトガル、1250-203
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Katowice、ポーランド、40-044
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lublin、ポーランド、20-954
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Olesnica、ポーランド
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Mexico City、メキシコ、06700
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Monterrey、メキシコ、64410
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Changhua、台湾、500
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Neihu Taipei、台湾、114
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Yungkang City、台湾、710
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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:
- Type 2 diabetes
- Non smoker
- Normal lung function
Exclusion Criteria:
- Pulmonary, hepatic, or renal disease
- Congestive heart failure
- Active malignancy
- Systemic glucocorticoid therapy
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 |
|---|---|
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実験的：1
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patient specific dose, inhaled, before meals, 24 months
他の名前：
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アクティブコンパレータ：2
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patient specific dose, injectable, before meals, 24 months
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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 |
時間枠 |
|---|---|
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To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin
時間枠：6 months
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6 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin
時間枠：24 months
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24 months
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To compare inhaled human insulin to injectable insulin over time with respect to change on body weight
時間枠：baseline and every visit
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baseline and every visit
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To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction
時間枠：baseline, 6 months, 12 months, 18 months, 24 months
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baseline, 6 months, 12 months, 18 months, 24 months
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To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c
時間枠：baseline and every visit
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baseline and every visit
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To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia
時間枠：throughout the study
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throughout the study
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To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements
時間枠：24 months
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24 months
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To test dose titration methods
時間枠：6 months
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6 months
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To assess inhaler reliability
時間枠：throughout the study
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throughout the study
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To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients
時間枠：3 months, 6 months
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3 months, 6 months
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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
協力者
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
2006年4月1日
一次修了 (実際)
2008年5月1日
研究の完了 (実際)
2008年5月1日
試験登録日
最初に提出
2006年5月10日
QC基準を満たした最初の提出物
2006年5月10日
最初の投稿 (見積もり)
2006年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2019年9月16日
QC基準を満たした最後の更新が送信されました
2019年9月6日
最終確認日
2019年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 9626
- H7U-MC-IDAU (その他の識別子：Eli Lilly and Company)
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
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD 共有時間枠
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD 共有アクセス基準
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
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。