The Effect of LY2409021 on Blood Sugar Levels When Glucagon Levels Are Increased in Healthy Male Participants

The Effect of LY2409021 on Blood Glucose Concentrations During Hyperglucagonaemia in Healthy Male Subjects

This is a study to measure the effect that various doses of LY2409021 have on blood sugar levels and on the amount of glucose released by the liver, when glucagon is given to increase these. Each participant may receive up to 2 single doses of LY2409021 in 2 different study periods, with a minimum 13-day washout between dosing periods. This study is approximately 9 weeks long, not including screening. A screening appointment is required within 6 weeks prior to the start of the study.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: LY2409021

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Must be a healthy male
• Have a screening body mass index (BMI) of 18.5 to 29.9 kg/m^2 inclusive
• Have a fasting blood glucose between 3.0-6.0 millimoles/liter (mmol/L) (inclusive) at screening

Exclusion Criteria:

• Are allergic to LY2409021, insulin, glucagon, somatostatin, or similar drugs
• Have a regular alcohol intake greater than 21 units/week, 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)
• Are currently smokers or have used tobacco products on a regular basis in the 6 months prior to screening
• Have received any medication known to affect glucose metabolism in the 1 month before the study
• Have a significant blood disorder and/or donated blood (450 mL or more) in the last 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Administered once, orally	Drug: Placebo; Administered orally, single dose
Experimental: 10 mg LY2409021; 10 mg LY2409021 administered once, orally	Drug: LY2409021; Administered orally, single dose
Experimental: 22.5 mg LY2409021; 22.5 mg LY2409021 administered once, orally	Drug: LY2409021; Administered orally, single dose
Experimental: 60 mg LY2409021; 60 mg LY2409021 administered once, orally	Drug: LY2409021; Administered orally, single dose
Experimental: 200 mg LY2409021; 200 mg LY2409021 administered once, orally	Drug: LY2409021; Administered orally, single dose
Experimental: 500 mg LY2409021; 500 mg LY2409021 administered once, orally	Drug: LY2409021; Administered orally, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum glucose response during a 3-hour glucagon infusion	During a 3-hour glucagon infusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Total glucose released from the liver during a 3-hour glucagon infusion	During a 3-hour glucagon infusion
Maximum glucose release from the liver during a 3-hour glucagon infusion	During a 3-hour glucagon infusion

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: May 23, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 25, 2012

Study Record Updates

• Last Update Posted (Estimate): May 25, 2012
• Last Update Submitted That Met QC Criteria: May 23, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 11165 (DAIDS ES Registry Number); I1R-FW-GLBC (Other Identifier: Eli Lilly and Company)