A Study of Multiple Doses of LY2922470 in Participants With Diabetes

Study Overview
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Brief Summary
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The main purpose of this study is to determine the safety of LY2922470, taken as oral capsules, once or twice daily for approximately 28 days, in participants with diabetes. It also aims to determine how long the drug stays in the body and how it affects blood sugar levels. A screening appointment is required within 28 days before the start of the study and a follow up appointment is required approximately 14 days after the last study dose is taken.

Official Title
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of LY2922470 in Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Placebo
* Drug: LY2922470


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be a male, or a female who cannot become pregnant, and who has type 2 diabetes Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening Have a screening body mass index (BMI) of 18.0 to 45.0 kilograms per square meter (kg/m^2) Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study Exclusion Criteria: Are currently participating in another clinical study or completed one in the last 30 days 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 or hepatitis C Are infected with human immunodeficiency virus (HIV) Have donated blood equal to or more than 500 mL within 56 days before the first dose of drug or have donated plasma within 7 days before the first dose or provided any blood donation within the last month from screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Multiple oral dose of placebo administered to participants with diabetes once or twice daily for 28 days | Drug: Placebo<br>* Administered orally as capsules<br>|
| Experimental: LY2922470<br>Multiple ascending dose of LY292470 (starting at 60 mg) administered orally to participants with diabetes once or twice daily for 28 days | Drug: LY2922470<br>* Administered orally as capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline through Study Completion (up to 56 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 |  | Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose | 
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 |  | Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose | 
| Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 |  | Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose | 
| Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 |  | Baseline, Day 28 | 
| Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28 |  | Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours Postdose | 
| Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28 |  | Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours Postdose |