A Study of Multiple Increasing Doses of LY2409021 in Participants With Type 2 Diabetes

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: LY2409021

Study type: Interventional

Funder types: Industry

Identifiers

NCT01606397

11071 (Registry Identifier)

I1R-FW-GLBB (Other Identifier)

Details and patient eligibility

About

The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The primary purpose of this study is to help answer the following research questions, and not to provide treatment for diabetes :

• The safety of LY2409021 and any side effects that might be associated with it following 4 weeks of doses
• How long it takes the body to absorb and remove LY2409021 following dosing over 4 weeks
• How daily dosing of LY2409021 affects blood levels of sugar (glucose), insulin and other naturally occurring substances before and after a meal
• How LY2409021 works when given with metformin
• How daily dosing of LY2409021 affects the cells that produce insulin

Enrollment: 50 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be either a male, or a female who cannot become pregnant, who has type 2 diabetes and is either controlling diabetes through diet and exercise, or taking metformin
• Have an hemoglobin A1c (HbA1c) value at screening of greater than or equal to 6.5% and less than or equal to 10.0% on a stable treatment regimen at the time of measurement
• Have a screening body mass index (BMI) of 20 to 40 kg/m^2 inclusive
• Have a blood pressure reading at screening of between 90 to 160 millimeters of mercury (mmHg) (systolic) and 40 to 95 mmHg (diastolic)

Exclusion criteria

• Have used insulin for diabetic control within 1 year of study entry
• Have used thiazolidinediones within 3 months, or any other drugs for treatment of hyperglycemia (except metformin) within 1 month, prior to first planned dosing. Metformin is acceptable for this study.
• Have clinically significant coronary artery disease
• Have clinically significant peripheral vascular disease
• Have clinical evidence of active diabetic proliferative retinopathy
• Have known significant autonomic neuropathy as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis
• Impaired renal function (serum creatinine greater than 115 micromoles/liter [μmol/L] [1.3 mg/dL] in women, greater than 130 μmol/L [1.5 mg/dL] in men)
• Have triglycerides greater than 4.5 millimoles per liter (mmol/L) [approximately 400 mg/dL] at screening
• Were hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
• Are allergic to LY2409021 or similar drugs
• Have history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (other than diabetes), hematological, or neurological disorders capable of significantly altering the absorption, or metabolism or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data
• Have used systemic glucocorticoids within 1 month prior to first dosing
• Have donated 450 mL or more of blood in the last 3 months or have donated any blood within the last month
• Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo administered orally once daily for 4 weeks

Treatment:

Drug: Placebo

5 mg LY2409021

Experimental group

Description:

5 mg LY2409021 administered orally once daily for 4 weeks

Treatment:

Drug: LY2409021

30 mg LY2409021

Experimental group

Description:

30 mg LY2409021 administered orally once daily for 4 weeks

Treatment:

Drug: LY2409021

60 mg LY2409021

Experimental group

Description:

60 mg LY2409021 administered orally once daily for 4 weeks

Treatment:

Drug: LY2409021

90 mg LY2409021

Experimental group

Description:

90 mg LY2409021 administered orally once daily for 4 weeks

Treatment:

Drug: LY2409021