A Study of Multiple Doses of LY2922470 in Participants With Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867216
• Other study ID #: 14797
• Secondary ID: I6K-FW-GLEB
• Status: Completed
• Phase: Phase 1
• Start date: June 2013
• Est. completion date: January 2014

Study information

• Verified date: July 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
Administered orally as capsules
• LY2922470
Administered orally as capsules

Locations

Country	Name	City	State
United States	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.	Chula Vista	California
United States	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	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.	Eatontown	New Jersey
United States	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.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28		Baseline, Day 28
Secondary	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
Secondary	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