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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01606423

Enrollment

Registered

2012-05-25

Start date

2007-11-30

Completion date

2008-03-31

Last updated

2012-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief 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.

Interventions

DRUGPlacebo

Administered orally, single dose

DRUGLY2409021

Administered orally, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

21 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026