A Study of Multiple Doses of LY2922470 in Participants With Diabetes

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: LY2922470

• Registration Number: NCT01867216
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-29
• Study Start: 2013-06
• Study First Posted: 2013-06-03
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2017-09-27
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-25
• Last Update Submitted: 2018-07-25
• Results First Posted: 2018-07-26
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Multiple oral dose of placebo administered to participants with diabetes once or twice daily for 28 days
LY2922470	LY2922470	Multiple ascending dose of LY292470 (starting at 60 mg) administered orally to participants with diabetes once or twice daily for 28 days

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Study Completion (up to 56 days)	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

Name	Time	Method
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

Trial Locations

Locations (1)

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.; 🇺🇸 Dallas, Texas, United States