A First-in-Human Study of LY2409021 in Healthy Participants and Participants With Type 2 Diabetes

NCT ID: NCT01606371

Last Updated: 2012-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2007-10-31

Brief Summary

The main purpose of this study is to determine the safety of LY2409021 in healthy participants and participants with diabetes. The study drug is given as single oral doses. Each participant can receive up to 3 doses, with a minimum 7 day washout between dosing periods. Side effects will be documented. This study is approximately 9 weeks long, not including screening. Screening is required within 6 weeks prior to the start of the study.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Healthy-Placebo

Placebo (capsule) administered once, orally

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally

Healthy-2.5 mg LY2409021

2.5 mg LY2409021 administered once, orally

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Administered orally

Healthy-10 mg LY2409021

10 mg LY2409021 administered once, orally

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Administered orally

Healthy-30 mg LY2409021

30 mg LY2409021 administered once, orally

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Administered orally

Healthy-100 mg LY2409021

100 mg LY2409021 administered once, orally

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Administered orally

Healthy-250 mg LY2409021

250 mg LY2409021 administered once, orally

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Administered orally

Healthy-500 mg LY2409021

500 mg LY2409021 administered once, orally

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Administered orally

Diabetic-Placebo

Placebo (capsule) administered once, orally

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally

Diabetic-75 mg LY2409021

75 mg LY2409021 administered once, orally

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Administered orally

Diabetic-200 mg LY2409021

200 mg LY2409021 administered once, orally

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Administered orally

Diabetic-500 mg LY2409021

500 mg LY2409021 administered once, orally

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Administered orally

Interventions

Placebo

Administered orally

Intervention Type: DRUG

LY2409021

Administered orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

For all participants:

• Must be either a male, or a female who cannot become pregnant, who is either healthy or have type 2 diabetes mellitus (T2DM) but not taking medication for diabetes
• Have an hemoglobin A1c (HbA1c) value of less than or equal to 10% at screening
• Have blood and urine laboratory test results that are acceptable for the study

For healthy participants:

• Have a screening body mass index (BMI) of 18.5 to 29.9 kg/m^2 inclusive
• Have a fasting blood glucose between 3.0-5.2 millimoles/liter (mmol/L) at screening
• Have plasma glucose, two hours after ingesting an oral 75 g glucose load, less than 7.8 mmol/L

For participants with type 2 diabetes mellitus (T2DM):

• Have a screening body mass index (BMI) of 18.5 to 35 kg/m^2 inclusive
• Must weigh 45 kg or more at screening
• Have a fasting blood glucose less than 11.1 mmol/L at screening
• Have plasma glucose, two hours after ingesting an oral 75 g glucose load, greater than or equal to 11.1 mmol/L

Exclusion Criteria

For all participants:

• Have participated in a study with a new drug in the last 30 days
• Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
• Have hypertension requiring more than single-agent therapy, or blood pressure greater than 140/90 millimeters of mercury (mmHg) on monotherapy
• Are allergic to LY2409021 or similar drugs
• 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)
• Intend to use other over-the-counter or prescribed medicines during 7 or 14 days respectively before the study, or during the study. Medicines for high cholesterol and high blood pressure are allowed if you have diabetes.
• Have a significant blood disorder and/or donated blood (450 ml or more) in the last 3 months

For participants with T2DM:

• Have signs of having serious problems with diabetes (For example, severe eye problems, poorly healing skin)
• Have a history of being in a coma due to low blood sugar

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-45 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

Singapore

References

Kelly RP, Garhyan P, Raddad E, Fu H, Lim CN, Prince MJ, Pinaire JA, Loh MT, Deeg MA. Short-term administration of the glucagon receptor antagonist LY2409021 lowers blood glucose in healthy people and in those with type 2 diabetes. Diabetes Obes Metab. 2015 Apr;17(4):414-22. doi: 10.1111/dom.12446. Epub 2015 Mar 2.

Reference Type: DERIVED

PMID: 25656305 (View on PubMed)

Other Identifiers

I1R-FW-GLBA

Identifier Type: OTHER

Identifier Source: secondary_id

10837

Identifier Type: -

Identifier Source: org_study_id