- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02942914
A Study of LY3209590 in Healthy Participants and Participants With Type 2 Diabetes
November 3, 2017 updated by: Eli Lilly and Company
A First-in-Human, Ascending-Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of a Single, Subcutaneous Dose of LY3209590
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Neuss, Germany, 41460
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: LY3209590
LY3209590 administered subcutaneously (SC).
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Administered SC
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PLACEBO_COMPARATOR: Placebo
Placebo (sterile saline) administered SC.
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Administered SC
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ACTIVE_COMPARATOR: Insulin Glargine (Lantus)
Insulin Glargine administered SC.
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Administered SC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Baseline through Day 31
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Pharmacokinetics: Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) of LY3209590
Time Frame: Baseline through Day 31
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Baseline through Day 31
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Pharmacodynamics: Average Glucose from 8-Point Glucose Profiles in Participants with T2DM treated with Placebo or LY3209590
Time Frame: Day 3
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Day 3
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 20, 2016
Primary Completion (ACTUAL)
October 18, 2017
Study Completion (ACTUAL)
October 18, 2017
Study Registration Dates
First Submitted
October 21, 2016
First Submitted That Met QC Criteria
October 21, 2016
First Posted (ESTIMATE)
October 24, 2016
Study Record Updates
Last Update Posted (ACTUAL)
November 7, 2017
Last Update Submitted That Met QC Criteria
November 3, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16129
- I8H-MC-BDCA (OTHER: Eli Lilly and Company)
- 2016-001048-20 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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