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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: LY2409021

• Registration Number: NCT01606397
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2012-05
• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-05-23
• Last Update Submitted: 2012-05-23
• Study First Posted: 2012-05-25
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered orally once daily for 4 weeks
5 mg LY2409021	LY2409021	5 mg LY2409021 administered orally once daily for 4 weeks
30 mg LY2409021	LY2409021	30 mg LY2409021 administered orally once daily for 4 weeks
60 mg LY2409021	LY2409021	60 mg LY2409021 administered orally once daily for 4 weeks
90 mg LY2409021	LY2409021	90 mg LY2409021 administered orally once daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Number of participants with one or more drug related adverse events (AEs) or any serious AEs	From first dose of study drug up to discharge (at least 28 days after last dose)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021	From first study drug dose to Day 28 post last dose
Pharmacokinetics: Maximum concentration (Cmax) of LY2409021	From first study drug dose to Day 28 post last dose
Change in fasting blood glucose level	From Day -1 to Day 28 of dosing
Change in incremental area under the curve (AUC) for glucose	From Day -1 to Day 28 of dosing
Change in homeostasis model assessment of beta cell function (HOMA-B)	From baseline to Day 28
Change in fasting glucagon level	From Day -1 to Day 28 of dosing
Change in fasting insulin level	From Day -1 to Day 28 of dosing
Change in fasting C-peptide level	From Day -1 to Day 28 of dosing
Change in fasting glucagon-like peptide-1 (GLP-1) level	From Day -1 to Day 28 of dosing

Trial Locations

Locations (1)

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.; 🇬🇧 Plymouth, United Kingdom