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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01606371
First received: May 23, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: LY2409021
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of participants with one or more drug related adverse events (AEs) or any serious AEs [ Time Frame: From first dose of study drug up to discharge (at least 14 days after last dose) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021 [ Time Frame: From each dose of study drug up to 14 days post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum concentration (Cmax) of LY2409021 [ Time Frame: From each dose of study drug up to 14 days post dose ] [ Designated as safety issue: No ]
  • Change in fasting blood glucose level [ Time Frame: From each dose of study drug up to 48 hours post dose ] [ Designated as safety issue: No ]
  • Change in fasting insulin level [ Time Frame: From each dose of study drug up to 48 hours post dose ] [ Designated as safety issue: No ]
  • Change in fasting glucagon level [ Time Frame: From each dose of study drug up to 48 hours post dose ] [ Designated as safety issue: No ]
  • Change in fasting glucagon-like peptide-1 (GLP-1) level [ Time Frame: From each dose of study drug up to 24 hours post dose ] [ Designated as safety issue: No ]
  • Glucose excursion after meals [ Time Frame: 28 hours after each dose ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Healthy-Placebo
Placebo (capsule) administered once, orally
Drug: Placebo
Administered orally
Experimental: Healthy-2.5 mg LY2409021
2.5 mg LY2409021 administered once, orally
Drug: LY2409021
Administered orally
Experimental: Healthy-10 mg LY2409021
10 mg LY2409021 administered once, orally
Drug: LY2409021
Administered orally
Experimental: Healthy-30 mg LY2409021
30 mg LY2409021 administered once, orally
Drug: LY2409021
Administered orally
Experimental: Healthy-100 mg LY2409021
100 mg LY2409021 administered once, orally
Drug: LY2409021
Administered orally
Experimental: Healthy-250 mg LY2409021
250 mg LY2409021 administered once, orally
Drug: LY2409021
Administered orally
Experimental: Healthy-500 mg LY2409021
500 mg LY2409021 administered once, orally
Drug: LY2409021
Administered orally
Placebo Comparator: Diabetic-Placebo
Placebo (capsule) administered once, orally
Drug: Placebo
Administered orally
Experimental: Diabetic-75 mg LY2409021
75 mg LY2409021 administered once, orally
Drug: LY2409021
Administered orally
Experimental: Diabetic-200 mg LY2409021
200 mg LY2409021 administered once, orally
Drug: LY2409021
Administered orally
Experimental: Diabetic-500 mg LY2409021
500 mg LY2409021 administered once, orally
Drug: LY2409021
Administered orally

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606371

Locations
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, Singapore
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01606371     History of Changes
Other Study ID Numbers: 10837, I1R-FW-GLBA
Study First Received: May 23, 2012
Last Updated: May 23, 2012
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014