Recruitment

Recruitment Status
Completed
Estimated Enrollment
70

Inclusion Criterias

Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening
Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
Have a screening body mass index (BMI) of 18.0 to 45.0 kilograms per square meter (kg/m^2)
...
Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening
Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
Have a screening body mass index (BMI) of 18.0 to 45.0 kilograms per square meter (kg/m^2)
Must be a male, or a female who cannot become pregnant, and who has type 2 diabetes
Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening

Exclusion Criterias

Are infected with human immunodeficiency virus (HIV)
Are infected with hepatitis B or hepatitis C
Are currently participating in another clinical study or completed one in the last 30 days
...
Are infected with human immunodeficiency virus (HIV)
Are infected with hepatitis B or hepatitis C
Are currently participating in another clinical study or completed one in the last 30 days
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
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

Summary

Conditions
Diabetes Mellitus, Type 2
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Inclusion Criterias

Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening
Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
Have a screening body mass index (BMI) of 18.0 to 45.0 kilograms per square meter (kg/m^2)
...
Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening
Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
Have a screening body mass index (BMI) of 18.0 to 45.0 kilograms per square meter (kg/m^2)
Must be a male, or a female who cannot become pregnant, and who has type 2 diabetes
Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening

Exclusion Criterias

Are infected with human immunodeficiency virus (HIV)
Are infected with hepatitis B or hepatitis C
Are currently participating in another clinical study or completed one in the last 30 days
...
Are infected with human immunodeficiency virus (HIV)
Are infected with hepatitis B or hepatitis C
Are currently participating in another clinical study or completed one in the last 30 days
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
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

Locations

New York, New York, 10013
Chula Vista, California, 91911
Eatontown, New Jersey, 07724
Dallas, Texas, 75247
...
New York, New York, 10013
Chula Vista, California, 91911
Eatontown, New Jersey, 07724
Dallas, Texas, 75247

Tracking Information

NCT #
NCT01867216
Collaborators
Not Provided
Investigators
Study Director: 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) Eli Lilly and Company