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Completed

NCT Number: NCT01606397

A Study of Multiple Increasing Doses of LY2409021 in Participants With Type 2 Diabetes

The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The primary purpose of this study is to help answer the following research questions, and not to provide treatment for diabetes :

* The safety of LY2409021 and any side effects that might be associated with it following 4 weeks of doses * How long it takes the body to absorb and remove LY2409021 following dosing over 4 weeks * How daily dosing of LY2409021 affects blood levels of sugar (glucose), insulin and other naturally occurring substances before and after a meal * How LY2409021 works when given with metformin * How daily dosing of LY2409021 affects the cells that produce insulin

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Key information

Age range

21 year–70 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

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must be either a male, or a female who cannot become pregnant, who has type 2 diabetes and is either controlling diabetes through diet and exercise, or taking metformin
  • Have an hemoglobin A1c (HbA1c) value at screening of greater than or equal to 6.5% and less than or equal to 10.0% on a stable treatment regimen at the time of measurement
  • Have a screening body mass index (BMI) of 20 to 40 kg/m^2 inclusive
  • Have a blood pressure reading at screening of between 90 to 160 millimeters of mercury (mmHg) (systolic) and 40 to 95 mmHg (diastolic)

Exclusion criteria

  • Have used insulin for diabetic control within 1 year of study entry
  • Have used thiazolidinediones within 3 months, or any other drugs for treatment of hyperglycemia (except metformin) within 1 month, prior to first planned dosing. Metformin is acceptable for this study.
  • Have clinically significant coronary artery disease
  • Have clinically significant peripheral vascular disease
  • Have clinical evidence of active diabetic proliferative retinopathy
  • Have known significant autonomic neuropathy as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis
  • Impaired renal function (serum creatinine greater than 115 micromoles/liter [μmol/L] [1.3 mg/dL] in women, greater than 130 μmol/L [1.5 mg/dL] in men)
  • Have triglycerides greater than 4.5 millimoles per liter (mmol/L) [approximately 400 mg/dL] at screening
  • Were hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
  • Are allergic to LY2409021 or similar drugs
  • Have history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (other than diabetes), hematological, or neurological disorders capable of significantly altering the absorption, or metabolism or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data
  • Have used systemic glucocorticoids within 1 month prior to first dosing
  • Have donated 450 mL or more of blood in the last 3 months or have donated any blood within the last month
  • 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)

Treatment and study plan

Placebo

Drug

Administered orally (capsule)

LY2409021

Drug

Administered orally (capsule)

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 28 days after last dose)

Secondary outcomes

  1. Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021

    Time frame: From first study drug dose to Day 28 post last dose

  2. Pharmacokinetics: Maximum concentration (Cmax) of LY2409021

    Time frame: From first study drug dose to Day 28 post last dose

  3. Change in fasting blood glucose level

    Time frame: From Day -1 to Day 28 of dosing

  4. Change in incremental area under the curve (AUC) for glucose

    Time frame: From Day -1 to Day 28 of dosing

  5. Change in homeostasis model assessment of beta cell function (HOMA-B)

    Time frame: From baseline to Day 28

  6. Change in fasting glucagon level

    Time frame: From Day -1 to Day 28 of dosing

  7. Change in fasting insulin level

    Time frame: From Day -1 to Day 28 of dosing

  8. Change in fasting C-peptide level

    Time frame: From Day -1 to Day 28 of dosing

  9. Change in fasting glucagon-like peptide-1 (GLP-1) level

    Time frame: From Day -1 to Day 28 of dosing

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Multiple Escalating Doses of LY2409021 in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
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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