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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01606371
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : May 25, 2012
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Placebo Drug: LY2409021 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : May 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021 [ Time Frame: From each dose of study drug up to 14 days post dose ]
  2. Pharmacokinetics: Maximum concentration (Cmax) of LY2409021 [ Time Frame: From each dose of study drug up to 14 days post dose ]
  3. Change in fasting blood glucose level [ Time Frame: From each dose of study drug up to 48 hours post dose ]
  4. Change in fasting insulin level [ Time Frame: From each dose of study drug up to 48 hours post dose ]
  5. Change in fasting glucagon level [ Time Frame: From each dose of study drug up to 48 hours post dose ]
  6. Change in fasting glucagon-like peptide-1 (GLP-1) level [ Time Frame: From each dose of study drug up to 24 hours post dose ]
  7. Glucose excursion after meals [ Time Frame: 28 hours after each dose ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606371


Locations
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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
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01606371    
Other Study ID Numbers: 10837
I1R-FW-GLBA ( Other Identifier: Eli Lilly and Company )
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases