Clinical trial NCT01867216: A Study of Multiple Doses of LY2922470 in Participants With Diabetes
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of LY2922470 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-06-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Study Completion (up to 56 days)
Secondary outcomes:
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470
timeFrame: 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
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470
timeFrame: 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
measure: Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470
timeFrame: 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
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28
timeFrame: Baseline, Day 28
measure: Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28
timeFrame: Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours Postdose
measure: Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28
timeFrame: Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours Postdose
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: 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.
state: California
city: Eatontown
country: United States
facility: 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.
state: New Jersey
city: New York
country: United States
facility: 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.
state: New York
city: Dallas
country: United States
facility: 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.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: