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Completed

NCT Number: NCT01606371

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

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Administered orally

LY2409021

Drug

Administered orally

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 25, 2012
Registry last updated
May 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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