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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2409021 After Escalating Single Oral Dose Administration in Healthy Subjects and Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606371
• Other study ID #: 10837
• Secondary ID: I1R-FW-GLBA
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2012
• Last updated: May 23, 2012
• Start date: May 2007
• Est. completion date: October 2007

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
Administered orally
• LY2409021
Administered orally

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	Number of participants with one or more drug related adverse events (AEs) or any serious AEs		From first dose of study drug up to discharge (at least 14 days after last dose)	Yes
Secondary	Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021		From each dose of study drug up to 14 days post dose	No
Secondary	Pharmacokinetics: Maximum concentration (Cmax) of LY2409021		From each dose of study drug up to 14 days post dose	No
Secondary	Change in fasting blood glucose level		From each dose of study drug up to 48 hours post dose	No
Secondary	Change in fasting insulin level		From each dose of study drug up to 48 hours post dose	No
Secondary	Change in fasting glucagon level		From each dose of study drug up to 48 hours post dose	No
Secondary	Change in fasting glucagon-like peptide-1 (GLP-1) level		From each dose of study drug up to 24 hours post dose	No
Secondary	Glucose excursion after meals		28 hours after each dose	No