A Study of LY2922083 in Healthy Participants and Participants With Diabetes

NCT ID: NCT01748552

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-08-31

Brief Summary

The aim of this trial is to evaluate the safety of the study drug in healthy participants and participants with diabetes. It will investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

The study consists of two parts. Part A will study healthy participants in up to 3 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 6 weeks.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Placebo (Part A)

Single oral dose of placebo administered to healthy participants in up to 1 of 3 study periods in Part A

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally as capsules

LY2922083 (Part A)

Single ascending dose of LY2922083 (starting at 0.5 milligrams \[mg\]) administered orally to healthy participants in up to 2 of 3 study periods in Part A

Group Type: EXPERIMENTAL

LY2922083

Intervention Type: DRUG

Administered orally as capsules

Placebo (Part B)

Single oral dose of placebo administered to participants with type 2 diabetes mellitus (T2DM) in up to 1 of 3 study periods in Part B

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally as capsules

LY2922083 (Part B)

Single ascending dose of LY2922083 administered orally to participants with T2DM in up to 2 of 3 study periods in Part B. Dose determined by Part A

Group Type: EXPERIMENTAL

LY2922083

Intervention Type: DRUG

Administered orally as capsules

Interventions

Placebo

Administered orally as capsules

Intervention Type: DRUG

LY2922083

Administered orally as capsules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

For all 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
• Have a screening body mass index (BMI) of at least 18.0 kilograms per square meter (kg/m^2)
• Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study

For participants with T2DM:

• Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
• Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6% and less than or equal to 11% at screening

Exclusion Criteria

For all participants :

• Are currently participating in another clinical study or completed one in the last 30 days
• Are allergic to LY2922083 or other related drugs
• 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 electrocardiogram (ECG) readings that are not suitable for the study
• Have a history of hepatitis or jaundice
• Are infected with hepatitis B
• Are infected with hepatitis C
• Are infected with human immunodeficiency virus (HIV)
• Have donated more than 450 milliliters (mL) of blood in the last 3 months or have donated any blood in the last month
• 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)
• Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic

For participants with T2DM :

• Have had heart disease or stroke within 6 months before entering the study
• Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor
• Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
• Have used insulin to control diabetes in the last 1 year
• Show symptoms of high blood sugar (for example, frequent urination, always feeling thirsty, or unexpected weight loss)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

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.

Singapore, , Singapore

Countries

Singapore

Other Identifiers

I6J-FW-PRBA

Identifier Type: OTHER

Identifier Source: secondary_id

14793

Identifier Type: -

Identifier Source: org_study_id