A Study of LY3209590 in Healthy Participants and Participants With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
LY3209590
Placebo
Insulin Glargine
Sponsored by

About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
For all study participants:
- Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes for at least 1 year
- Male participants with female partners who can become pregnant must agree to use an effective method of birth control during the study and for 4 months after study drug dosing
- Have a body mass index (BMI) of greater than 18.5 kilogram per square meter (kg/m²) and less than or equal to 35 kg/m² at screening
- Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
- Have venous access sufficient to allow blood sampling
For participants with Type 2 Diabetes Mellitus (T2DM):
- Have T2DM controlled with diet and exercise alone or are stable on metformin for at least 30 days
- If taken, prescription medications for medical conditions (e.g.antihypertensive agents, aspirin or lipid lowering agents) are stable for at least 4 weeks
- Have a hemoglobin A1c (HbA1c) greater than or equal to 7.0% and less than or equal to 9.5%
Exclusion Criteria:
For all study participants:
- Are currently participating in another clinical study
- Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
- Have donated blood or have had a loss of 500 milliliters (mL) or more in the last 3 months or have had any blood donation within the last month from screening
- Intend to start any new over-the-counter or prescription medications 7 and 14 days before planned dosing
For participants with T2DM:
- Have taken any glucose-lowering medications, other than metformin, including insulin, in the past 3 months before screening
- Have had more than 1 episode of severe hypoglycemia, within 6 months before entry into the study, or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- Have had a blood transfusion or severe blood loss in the past 3 months, or any blood disorder that could interfere with the understanding of the results of the study
- Have received chronic (lasting greater than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, and inhaled preparations) in the 3 past months, or have received any glucocorticoid therapy within 30 days before screening
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, 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 Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
LY3209590
Placebo
Insulin Glargine (Lantus)
Arm Description
LY3209590 administered subcutaneously (SC).
Placebo (sterile saline) administered SC.
Insulin Glargine administered SC.
Outcomes
Primary Outcome Measures
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary Outcome Measures
Pharmacokinetics: Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) of LY3209590
Pharmacodynamics: Average Glucose from 8-Point Glucose Profiles in Participants with T2DM treated with Placebo or LY3209590
Full Information
NCT ID
NCT02942914
First Posted
October 21, 2016
Last Updated
November 3, 2017
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT02942914
Brief Title
A Study of LY3209590 in Healthy Participants and Participants With Type 2 Diabetes
Official Title
A First-in-Human, Ascending-Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of a Single, Subcutaneous Dose of LY3209590
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 20, 2016 (Actual)
Primary Completion Date
October 18, 2017 (Actual)
Study Completion Date
October 18, 2017 (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
This trial is conducted to evaluate the safety of a study drug given by injection under the skin to healthy participants and participants with type 2 diabetes. It will also investigate how the body processes the study drug and the effect of the study drug on blood sugar levels. Information about any side effects and tolerability will be documented. This study is approximately 30 days for each participant, not including screening. Screening is required within 28 days 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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3209590
Arm Type
Experimental
Arm Description
LY3209590 administered subcutaneously (SC).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (sterile saline) administered SC.
Arm Title
Insulin Glargine (Lantus)
Arm Type
Active Comparator
Arm Description
Insulin Glargine administered SC.
Intervention Type
Drug
Intervention Name(s)
LY3209590
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame
Baseline through Day 31
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) of LY3209590
Time Frame
Baseline through Day 31
Title
Pharmacodynamics: Average Glucose from 8-Point Glucose Profiles in Participants with T2DM treated with Placebo or LY3209590
Time Frame
Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For all study participants:
Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes for at least 1 year
Male participants with female partners who can become pregnant must agree to use an effective method of birth control during the study and for 4 months after study drug dosing
Have a body mass index (BMI) of greater than 18.5 kilogram per square meter (kg/m²) and less than or equal to 35 kg/m² at screening
Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
Have venous access sufficient to allow blood sampling
For participants with Type 2 Diabetes Mellitus (T2DM):
Have T2DM controlled with diet and exercise alone or are stable on metformin for at least 30 days
If taken, prescription medications for medical conditions (e.g.antihypertensive agents, aspirin or lipid lowering agents) are stable for at least 4 weeks
Have a hemoglobin A1c (HbA1c) greater than or equal to 7.0% and less than or equal to 9.5%
Exclusion Criteria:
For all study participants:
Are currently participating in another clinical study
Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
Have donated blood or have had a loss of 500 milliliters (mL) or more in the last 3 months or have had any blood donation within the last month from screening
Intend to start any new over-the-counter or prescription medications 7 and 14 days before planned dosing
For participants with T2DM:
Have taken any glucose-lowering medications, other than metformin, including insulin, in the past 3 months before screening
Have had more than 1 episode of severe hypoglycemia, within 6 months before entry into the study, or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
Have had a blood transfusion or severe blood loss in the past 3 months, or any blood disorder that could interfere with the understanding of the results of the study
Have received chronic (lasting greater than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, and inhaled preparations) in the 3 past months, or have received any glucocorticoid therapy within 30 days before screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study of LY3209590 in Healthy Participants and Participants With Type 2 Diabetes
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