Back to resultsA First-in-Human Study of LY2409021 in Healthy Participants and Participants With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Placebo
LY2409021
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
For all participants:
- Must be either a male, or a female who cannot become pregnant, who is either healthy or have type 2 diabetes mellitus (T2DM) but not taking medication for diabetes
- Have an hemoglobin A1c (HbA1c) value of less than or equal to 10% at screening
- Have blood and urine laboratory test results that are acceptable for the study
For healthy participants:
- Have a screening body mass index (BMI) of 18.5 to 29.9 kg/m^2 inclusive
- Have a fasting blood glucose between 3.0-5.2 millimoles/liter (mmol/L) at screening
- Have plasma glucose, two hours after ingesting an oral 75 g glucose load, less than 7.8 mmol/L
For participants with type 2 diabetes mellitus (T2DM):
- Have a screening body mass index (BMI) of 18.5 to 35 kg/m^2 inclusive
- Must weigh 45 kg or more at screening
- Have a fasting blood glucose less than 11.1 mmol/L at screening
- Have plasma glucose, two hours after ingesting an oral 75 g glucose load, greater than or equal to 11.1 mmol/L
Exclusion Criteria:
For all participants:
- Have participated in a study with a new drug in the last 30 days
- Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
- Have hypertension requiring more than single-agent therapy, or blood pressure greater than 140/90 millimeters of mercury (mmHg) on monotherapy
- Are allergic to LY2409021 or similar drugs
- Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
- Intend to use other over-the-counter or prescribed medicines during 7 or 14 days respectively before the study, or during the study. Medicines for high cholesterol and high blood pressure are allowed if you have diabetes.
- Have a significant blood disorder and/or donated blood (450 ml or more) in the last 3 months
For participants with T2DM:
- Have signs of having serious problems with diabetes (For example, severe eye problems, poorly healing skin)
- Have a history of being in a coma due to low blood sugar
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Healthy-Placebo
Healthy-2.5 mg LY2409021
Healthy-10 mg LY2409021
Healthy-30 mg LY2409021
Healthy-100 mg LY2409021
Healthy-250 mg LY2409021
Healthy-500 mg LY2409021
Diabetic-Placebo
Diabetic-75 mg LY2409021
Diabetic-200 mg LY2409021
Diabetic-500 mg LY2409021
Arm Description
Placebo (capsule) administered once, orally
2.5 mg LY2409021 administered once, orally
10 mg LY2409021 administered once, orally
30 mg LY2409021 administered once, orally
100 mg LY2409021 administered once, orally
250 mg LY2409021 administered once, orally
500 mg LY2409021 administered once, orally
Placebo (capsule) administered once, orally
75 mg LY2409021 administered once, orally
200 mg LY2409021 administered once, orally
500 mg LY2409021 administered once, orally
Outcomes
Primary Outcome Measures
Number of participants with one or more drug related adverse events (AEs) or any serious AEs
Secondary Outcome Measures
Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021
Pharmacokinetics: Maximum concentration (Cmax) of LY2409021
Change in fasting blood glucose level
Change in fasting insulin level
Change in fasting glucagon level
Change in fasting glucagon-like peptide-1 (GLP-1) level
Glucose excursion after meals
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01606371
Brief Title
A First-in-Human Study of LY2409021 in Healthy Participants and Participants With Type 2 Diabetes
Official Title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2409021 After Escalating Single Oral Dose Administration in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to determine the safety of LY2409021 in healthy participants and participants with diabetes. The study drug is given as single oral doses. Each participant can receive up to 3 doses, with a minimum 7 day washout between dosing periods. Side effects will be documented. This study is approximately 9 weeks long, not including screening. Screening is required within 6 weeks prior to the start of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy-Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (capsule) administered once, orally
Arm Title
Healthy-2.5 mg LY2409021
Arm Type
Experimental
Arm Description
2.5 mg LY2409021 administered once, orally
Arm Title
Healthy-10 mg LY2409021
Arm Type
Experimental
Arm Description
10 mg LY2409021 administered once, orally
Arm Title
Healthy-30 mg LY2409021
Arm Type
Experimental
Arm Description
30 mg LY2409021 administered once, orally
Arm Title
Healthy-100 mg LY2409021
Arm Type
Experimental
Arm Description
100 mg LY2409021 administered once, orally
Arm Title
Healthy-250 mg LY2409021
Arm Type
Experimental
Arm Description
250 mg LY2409021 administered once, orally
Arm Title
Healthy-500 mg LY2409021
Arm Type
Experimental
Arm Description
500 mg LY2409021 administered once, orally
Arm Title
Diabetic-Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (capsule) administered once, orally
Arm Title
Diabetic-75 mg LY2409021
Arm Type
Experimental
Arm Description
75 mg LY2409021 administered once, orally
Arm Title
Diabetic-200 mg LY2409021
Arm Type
Experimental
Arm Description
200 mg LY2409021 administered once, orally
Arm Title
Diabetic-500 mg LY2409021
Arm Type
Experimental
Arm Description
500 mg LY2409021 administered once, orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
LY2409021
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Number of participants with one or more drug related adverse events (AEs) or any serious AEs
Time Frame
From first dose of study drug up to discharge (at least 14 days after last dose)
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021
Time Frame
From each dose of study drug up to 14 days post dose
Title
Pharmacokinetics: Maximum concentration (Cmax) of LY2409021
Time Frame
From each dose of study drug up to 14 days post dose
Title
Change in fasting blood glucose level
Time Frame
From each dose of study drug up to 48 hours post dose
Title
Change in fasting insulin level
Time Frame
From each dose of study drug up to 48 hours post dose
Title
Change in fasting glucagon level
Time Frame
From each dose of study drug up to 48 hours post dose
Title
Change in fasting glucagon-like peptide-1 (GLP-1) level
Time Frame
From each dose of study drug up to 24 hours post dose
Title
Glucose excursion after meals
Time Frame
28 hours after each dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For all participants:
Must be either a male, or a female who cannot become pregnant, who is either healthy or have type 2 diabetes mellitus (T2DM) but not taking medication for diabetes
Have an hemoglobin A1c (HbA1c) value of less than or equal to 10% at screening
Have blood and urine laboratory test results that are acceptable for the study
For healthy participants:
Have a screening body mass index (BMI) of 18.5 to 29.9 kg/m^2 inclusive
Have a fasting blood glucose between 3.0-5.2 millimoles/liter (mmol/L) at screening
Have plasma glucose, two hours after ingesting an oral 75 g glucose load, less than 7.8 mmol/L
For participants with type 2 diabetes mellitus (T2DM):
Have a screening body mass index (BMI) of 18.5 to 35 kg/m^2 inclusive
Must weigh 45 kg or more at screening
Have a fasting blood glucose less than 11.1 mmol/L at screening
Have plasma glucose, two hours after ingesting an oral 75 g glucose load, greater than or equal to 11.1 mmol/L
Exclusion Criteria:
For all participants:
Have participated in a study with a new drug in the last 30 days
Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
Have hypertension requiring more than single-agent therapy, or blood pressure greater than 140/90 millimeters of mercury (mmHg) on monotherapy
Are allergic to LY2409021 or similar drugs
Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
Intend to use other over-the-counter or prescribed medicines during 7 or 14 days respectively before the study, or during the study. Medicines for high cholesterol and high blood pressure are allowed if you have diabetes.
Have a significant blood disorder and/or donated blood (450 ml or more) in the last 3 months
For participants with T2DM:
Have signs of having serious problems with diabetes (For example, severe eye problems, poorly healing skin)
Have a history of being in a coma due to low blood sugar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-45 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Singapore
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
25656305
Citation
Kelly RP, Garhyan P, Raddad E, Fu H, Lim CN, Prince MJ, Pinaire JA, Loh MT, Deeg MA. Short-term administration of the glucagon receptor antagonist LY2409021 lowers blood glucose in healthy people and in those with type 2 diabetes. Diabetes Obes Metab. 2015 Apr;17(4):414-22. doi: 10.1111/dom.12446. Epub 2015 Mar 2.
Results Reference
derived
Learn more about this trial
A First-in-Human Study of LY2409021 in Healthy Participants and Participants With Type 2 Diabetes
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