A Study of Single and Repeated Doses of Glucagon Administered to Participants With Diabetes
2019年11月25日 更新者:Eli Lilly and Company
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
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 50 days for each participant.
研究概览
研究类型
介入性
注册 (实际的)
12
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Quebec
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Mount-Royal、Quebec、加拿大、H3P 3P1
- 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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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Treatment 1
Treatment 1, single nasal glucagon (NG) dose of 3 milligram (mg).
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鼻内给药。
其他名称:
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实验性的:Treatment 2
Treatment 2, NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later.
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鼻内给药。
其他名称:
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实验性的:Treatment 3
Treatment 3, NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later.
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鼻内给药。
其他名称:
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实验性的:Treatment 4
Treatment 4, NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.
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鼻内给药。
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon
大体时间: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
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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
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PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon
大体时间: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
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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
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PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
大体时间: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
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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
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PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
大体时间: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
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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
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Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₁.₅) of Blood Glucose (BG)
大体时间: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
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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
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PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
大体时间: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
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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
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PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)
大体时间: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
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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
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年6月1日
初级完成 (实际的)
2014年6月1日
研究完成 (实际的)
2014年8月1日
研究注册日期
首次提交
2016年5月26日
首先提交符合 QC 标准的
2016年6月17日
首次发布 (估计)
2016年6月21日
研究记录更新
最后更新发布 (实际的)
2019年12月13日
上次提交的符合 QC 标准的更新
2019年11月25日
最后验证
2019年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.