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A Study of Single and Repeated Doses of Glucagon Administered to Participants With Diabetes 第I相・フェーズ1 12

中止
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT02806960 は 1型糖尿病、2型糖尿病 に関する 基礎研究 の研究で、第I相・フェーズ1 介入研究 臨床試験 です。現在は 中止 で、2014年6月1日 から開始しています。12 名の参加者 の募集が計画されています。この試験は イーライリリー によって主導され、2014年8月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2019年12月13日 です。
概要
This study will investigate how the body processes nasal glucagon and the effect of nasal glucagon on the body. After an 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, the study drug will be delivered into the participant's nostril(s) (intranasally) once or twice in each of four study periods. The study is open to adults with type 1 or type 2 diabetes and is expected to last about ...もっと見る
公式タイトル

A Single Center, Randomized, 4-Period Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Single or Repeated 3 mg Doses of Intranasally Administered Glucagon in Adults With Type 1 or Type 2 Diabetes

疾患名
1型糖尿病2型糖尿病
その他の研究識別子
  • 16493
  • I8R-MC-IGBH (その他の識別子) (Eli Lilly and Company)
  • AMG110 (その他の識別子) (AMG Medical Inc)
  • AMG-P4-459 (その他の識別子) (AMG Medical Inc)
NCT番号
NCT02806960
開始日
2014-06
最終更新日
2019-12-13
終了予定日
2014-08
目標参加者数
12
試験の種類
介入研究
治験の相・段階
第I相・フェーズ1
状況
中止
主目的
基礎研究
割付方法
無作為化
介入モデル
クロスオーバー法
盲検化
単盲検
群（アーム）／介入
参加グループ/群介入/治療法
実験的Treatment 1
Treatment 1, single nasal glucagon (NG) dose of 3 milligram (mg).
Nasal Glucagon
Administered intranasally.
実験的Treatment 2
Treatment 2, NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later.
Nasal Glucagon
Administered intranasally.
実験的Treatment 3
Treatment 3, NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later.
Nasal Glucagon
Administered intranasally.
実験的Treatment 4
Treatment 4, NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.
Nasal Glucagon
Administered intranasally.
主要評価項目
評価指標指標の説明時間枠
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon
Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment
PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon
Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₁.₅) of Blood Glucose (BG)
Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, and 1.5 hours post dose for each treatment
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)
Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て

  • Males or females with a history of Type 1 or Type 2 insulin-using diabetes of at least 1 year duration (basal only, basal bolus, meal-time only, or twice a day pre-mixed insulin)

  • A female participant must meet one of the following criteria:

    • Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug.
    • Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses)

  • Participants with a body mass index (BMI) greater than or equal to 18.50 kilograms per square meter (kg/m²) and below 35.00 kg/m²

  • Light-, non- or ex-smokers

  • In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations

  • Females who are pregnant, actively attempting to get pregnant, or are lactating
  • History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs
  • Presence of significant gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the Investigator could interfere with the absorption, distribution, metabolism or excretion of drugs, or could potentiate or predispose to undesired effects
  • Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
  • Known presence of rare hereditary problems of galactose and /or lactose intolerance
  • Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor) Presence of clinically significant findings on nasal examination or bilateral anterior rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation, nasal tumors
  • Nasal surgery in the previous 28 days before Day 1 of this study
  • Daily use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this study
  • Any other concomitant maintenance therapy that would influence the outcome of the trial or compromise the safety of the participant, at the discretion of the Investigator and the Sponsor, in the previous 28 days before Day 1 of this study
  • Significant history of drug dependency or alcohol abuse
  • Any clinically significant illness in the previous 28 days before Day 1 of this study
  • Any history of tuberculosis and/or prophylaxis for tuberculosis
  • Positive urine screening of alcohol and/or drugs of abuse
  • Concurrent participation or intention of participating in another clinical trial during this study
  • Participants who took an Investigational Product (in another clinical trial) in the previous 28 days before Day 1 of this study or who have already participated in this clinical study
  • Participants who donated 50 milliliters (mL) or more of blood in the previous 28 days before Day 1 of this study
  • Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before Day 1 of this study
Eli Lilly and Company logoイーライリリー362 件のアクティブな治験を探索
Locemia Solutions ULC logoLocemia Solutions ULC
連絡先情報がありません。
1 1カ国の場所

Quebec

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., Mount Royal, Quebec, H3P 3P1, Canada