A First-in-Human, Ascending-Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of a Single, Subcutaneous Dose of LY3209590

Eli Lilly and Company1 site in 1 country80 target enrollmentDecember 20, 2016

ConditionsDiabetes Mellitus, Type 2

InterventionsLY3209590 Placebo Insulin Glargine

DrugsLY3209590 Placebo Insulin Glargine

Overview

Phase: Phase 1
Intervention: LY3209590
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Enrollment: 80
Locations: 1
Primary Endpoint: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 20, 2016

End Date

October 18, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

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

Arms & Interventions

LY3209590

LY3209590 administered subcutaneously (SC).

Intervention: LY3209590

Placebo

Placebo (sterile saline) administered SC.

Intervention: Placebo

Insulin Glargine (Lantus)

Insulin Glargine administered SC.

Intervention: Insulin Glargine

Outcomes

Primary Outcomes

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 Outcomes

Pharmacokinetics: Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) of LY3209590(Baseline through Day 31)
Pharmacodynamics: Average Glucose from 8-Point Glucose Profiles in Participants with T2DM treated with Placebo or LY3209590(Day 3)