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A Study of LY2922470 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
LY2922470
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

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 Type 2 Diabetes Mellitus (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 LY2922470 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
  • Are infected with hepatitis B
  • Are infected with human immunodeficiency virus (HIV)
  • Have donated more than 450 milliliter (mL) of blood in the last 3 months or if 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 (e.g.), 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)

LY2922470 (Part A)

Placebo (Part B)

LY2922470 (Part B)

Arm Description

Single oral dose of placebo administered to healthy participants in up to 1 of 4 study periods in Part A

Single ascending dose of LY2922470 [starting at 1 milligram (mg)] administered orally to healthy participants in up to 3 of 4 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 LY2922470 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 One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.

Secondary Outcome Measures

Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)]
Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470
Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [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 Zero to 6 Hours [AUEC(0-6)]
LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.

Full Information

First Posted
December 6, 2012
Last Updated
February 15, 2019
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01746017
Brief Title
A Study of LY2922470 in Healthy Participants and Participants With Diabetes
Official Title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY2922470 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (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
The aim of this trial is to evaluate the safety of the study drug in healthy participant and participant 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 4 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 5 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
26 (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 4 study periods in Part A
Arm Title
LY2922470 (Part A)
Arm Type
Experimental
Arm Description
Single ascending dose of LY2922470 [starting at 1 milligram (mg)] administered orally to healthy participants in up to 3 of 4 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
LY2922470 (Part B)
Arm Type
Experimental
Arm Description
Single ascending dose of LY2922470 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)
LY2922470
Intervention Description
Administered orally as capsules
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
Description
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.
Time Frame
Baseline to study completion up to 33 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)]
Time Frame
Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose
Title
Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470
Time Frame
Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose
Title
Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [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), 24 hours postdose
Title
Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [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), 6 hours postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 Type 2 Diabetes Mellitus (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 LY2922470 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 Are infected with hepatitis B Are infected with human immunodeficiency virus (HIV) Have donated more than 450 milliliter (mL) of blood in the last 3 months or if 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 (e.g.), 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
Country
Singapore

12. IPD Sharing Statement

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