- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01746017
A Study of LY2922470 in Healthy Participants and Participants With Diabetes
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY2922470 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Singapore, Singapore
- 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.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo (Part A)
Single oral dose of placebo administered to healthy participants in up to 1 of 4 study periods in Part A
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Administered orally as capsules
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Experimental: LY2922470 (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
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Administered orally as capsules
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Placebo Comparator: 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
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Administered orally as capsules
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Experimental: LY2922470 (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
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Administered orally as capsules
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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 to study completion up to 33 days
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A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.
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Baseline to study completion up to 33 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose
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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
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Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose
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Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)]
Time Frame: Baseline (predose for Part A and Day -1 time-matched for Part B), 24 hours postdose
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Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
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Baseline (predose for Part A and Day -1 time-matched for Part B), 24 hours postdose
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Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)]
Time Frame: Baseline (predose for Part A and Day -1 time-matched for Part B), 6 hours postdose
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LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
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Baseline (predose for Part A and Day -1 time-matched for Part B), 6 hours postdose
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14796
- I6K-FW-GLEA (Other Identifier: Eli Lilly and Company)
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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