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

Condition(s) targeted: Healthy Volunteers

Intervention: Placebo (Drug); LY2409021 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Primary outcome: Maximum glucose response during a 3-hour glucagon infusion

Secondary outcome:

Total glucose released from the liver during a 3-hour glucagon infusion

Maximum glucose release from the liver during a 3-hour glucagon infusion

Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

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

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., Singapore, Singapore

Starting date: November 2007
Last updated: May 23, 2012