A Study of Multiple Doses of LY2922470 in Participants With Diabetes

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: LY2922470; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01867216

I6K-FW-GLEB (Other Identifier)

14797

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Multiple oral dose of placebo administered to participants with diabetes once or twice daily for 28 days

Treatment:

Drug: Placebo

LY2922470

Experimental group

Description:

Multiple ascending dose of LY292470 (starting at 60 mg) administered orally to participants with diabetes once or twice daily for 28 days

Treatment:

Drug: LY2922470