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A Study of LY2922083 in Healthy Participants and Participants With Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Singapore

Study Type

Interventional

Intervention

Placebo

LY2922083

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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 Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo (Part A)

LY2922083 (Part A)

Placebo (Part B)

LY2922083 (Part B)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Number of Participants With 1 or More Serious Adverse Event(s) (SAEs)

Events deemed by the Investigator to be SAEs related to study drug administration are reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Secondary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration Curve From Time 0 to Infinite Time [AUC(0-∞)] of LY2922083

PK: Maximum Concentration (Cmax) of LY2922083

Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time 0 to 24 h Postdose [AUEC(0-24)]

Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.

Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time 0 to 6 h Postdose [AUEC(0-6)]

LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.

Full Information

NCT ID

NCT01748552

First Posted

December 10, 2012

Last Updated

June 24, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01748552

Brief Title

A Study of LY2922083 in Healthy Participants and Participants With Diabetes

Official Title

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY2922083 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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

Participant

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo (Part A)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

LY2922083 (Part A)

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo (Part B)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

LY2922083 (Part B)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally as capsules

Intervention Type

Drug

Intervention Name(s)

LY2922083

Intervention Description

Administered orally as capsules

Primary Outcome Measure Information:

Title

Number of Participants With 1 or More Serious Adverse Event(s) (SAEs)

Description

Time Frame

Baseline through study completion (up to 70 days)

Secondary Outcome Measure Information:

Title

Pharmacokinetics (PK): Area Under the Concentration Curve From Time 0 to Infinite Time [AUC(0-∞)] of LY2922083

Time Frame

Predose up to 72 hours (h) after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.)

Title

PK: Maximum Concentration (Cmax) of LY2922083

Time Frame

Predose up to 72 h after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.)

Title

Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time 0 to 24 h Postdose [AUEC(0-24)]

Description

Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.

Time Frame

Baseline (predose for Part A and Day -1 time-matched for Part B), up to 24 h postdose (1.5, 2.5, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, and 24 h postdose)

Title

Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time 0 to 6 h Postdose [AUEC(0-6)]

Description

LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.

Time Frame

Baseline (predose for Part A and Day -1 time-matched for Part B), up to 6 h postdose (1.5, 2.5, 4, 4.5, 5, and 6 h postdose)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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)

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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Singapore

ZIP/Postal Code

117597

Country

Singapore

12. IPD Sharing Statement

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A Study of LY2922083 in Healthy Participants and Participants With Diabetes

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