A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes
2015年2月20日 更新者：AstraZeneca
As exenatide slows the rate at which materials leave the stomach, it is likely to alter the rate of intestinal absorption of oral drugs when administered within a certain timeframe relative to exenatide.
In addition, the residence time within the stomach of other medication may be prolonged and data from this study will help assess the change in residence time in the presence of therapeutic doses of exenatide.
This study will also evaluate the relationship between blood levels of exenatide and parameters measuring rate of stomach emptying.
調査の概要
研究の種類
介入
入学 (実際)
17
段階
- フェーズ 1
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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Nottingham、イギリス
- Research Site
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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
25年～75年 (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:
- Subjects with at least 1 year history of type 2 diabetes mellitus.
- Subjects controlled by oral antidiabetic agents or diet and exercise demonstrated by a screening HbA1c ≥7.0% and ≤10.0%.
- Between the body mass index (BMI) of 19 kg/m2 and 40 kg/m2, inclusive.
Exclusion Criteria:
- Within 4 months of the initial dose of study drug, have received a drug that has not received regulatory approval for any indication.
- Persons who have previously completed or withdrawn from this study or any other study investigating exenatide.
- Subjects who are using drugs that significantly affect gastrointestinal motility (including acarbose, metoclopramide, and macrolide antibiotics).
- Subjects who intend to start new concomitant medication during the study, including over-the counter medication, apart from occasional intake of paracetamol or vitamin/mineral supplements. Anti-emetic medication may be permitted at the investigator's discretion, except those that affect gastrointestinal motility.
- Subjects who have used insulin for more than 4 weeks within 3 months prior to screening.
- Blood donation of more than 500 mL in the last 3 months of screening or any blood donation within the last month.
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：クロスオーバー割り当て
- マスキング：独身
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：Sequence 1
Exenatide 5 mcg - Exentatide 10 mcg - Placebo
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Period 1 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day.
Period 2 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day.
Period 3 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day.
A washout of at least 2.5 days will occur between each treatment period.
他の名前：
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実験的：Sequence 2
Exenatide 10 mcg - Placebo - Exenatide 5 mcg
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Period 1 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day.
Period 2 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day.
Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day.
A washout of at least 2.5 days will occur between each treatment period.
他の名前：
Period 1 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day.
Period 2 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day.
Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day.
A washout of at least 2.5 days will occur between each treatment period.
他の名前：
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実験的：Sequence 3
Placebo - Exenatide 5 mcg - Exenatide 10 mcg
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Period 1 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day.
Period 2 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day.
Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day.
A washout of at least 2.5 days will occur between each treatment period.
他の名前：
Period 1 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day.
Period 2 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day.
Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day.
A washout of at least 2.5 days will occur between each treatment period.
他の名前：
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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 |
メジャーの説明 |
時間枠 |
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To detect the mean difference in half gastric emptying time for a solid meal between any treatment and placebo
時間枠：up to 12 hours post meal consumption
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A dose of exenatide or placebo is given before the morning meal.
After eating the test meal, images will be recorded at approximately 5 minute intervals from ingestion of the test meal until 3 hours after the meal, then every 10 minutes until 6 hours after the meal.
In cases where significant radioactivity is observed at 6 hours after the meal, additional scintigraphic images may be taken periodically at the discretion of the investigator, until counts approach low values for up to 12 hours after the meal.
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up to 12 hours post meal consumption
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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。
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
2005年1月1日
一次修了 (実際)
2005年6月1日
研究の完了 (実際)
2005年6月1日
試験登録日
最初に提出
2007年8月14日
QC基準を満たした最初の提出物
2007年8月14日
最初の投稿 (見積もり)
2007年8月16日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年2月23日
QC基準を満たした最後の更新が送信されました
2015年2月20日
最終確認日
2015年1月1日
詳しくは
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
exenatide and placeboの臨床試験
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Shanghai Hengrui Pharmaceutical Co., Ltd.完了
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Palacky University完了