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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606423
• Other study ID #: 11165
• Secondary ID: I1R-FW-GLBC
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2012
• Last updated: May 23, 2012
• Start date: November 2007
• Est. completion date: March 2008

Study information

• Verified date: May 2012
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 55 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Placebo
Administered orally, single dose
• LY2409021
Administered orally, single dose

Locations

Country	Name	City	State
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.	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum glucose response during a 3-hour glucagon infusion		During a 3-hour glucagon infusion	No
Secondary	Total glucose released from the liver during a 3-hour glucagon infusion		During a 3-hour glucagon infusion	No
Secondary	Maximum glucose release from the liver during a 3-hour glucagon infusion		During a 3-hour glucagon infusion	No