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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01606397
First received: May 23, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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

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: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Multiple Escalating Doses of LY2409021 in 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 28 days after last dose) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021 [ Time Frame: From first study drug dose to Day 28 post last dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum concentration (Cmax) of LY2409021 [ Time Frame: From first study drug dose to Day 28 post last dose ] [ Designated as safety issue: No ]
  • Change in fasting blood glucose level [ Time Frame: From Day -1 to Day 28 of dosing ] [ Designated as safety issue: No ]
  • Change in incremental area under the curve (AUC) for glucose [ Time Frame: From Day -1 to Day 28 of dosing ] [ Designated as safety issue: No ]
  • Change in homeostasis model assessment of beta cell function (HOMA-B) [ Time Frame: From baseline to Day 28 ] [ Designated as safety issue: No ]
  • Change in fasting glucagon level [ Time Frame: From Day -1 to Day 28 of dosing ] [ Designated as safety issue: No ]
  • Change in fasting insulin level [ Time Frame: From Day -1 to Day 28 of dosing ] [ Designated as safety issue: No ]
  • Change in fasting C-peptide level [ Time Frame: From Day -1 to Day 28 of dosing ] [ Designated as safety issue: No ]
  • Change in fasting glucagon-like peptide-1 (GLP-1) level [ Time Frame: From Day -1 to Day 28 of dosing ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo administered orally once daily for 4 weeks
Drug: Placebo
Administered orally (capsule)
Experimental: 5 mg LY2409021
5 mg LY2409021 administered orally once daily for 4 weeks
Drug: LY2409021
Administered orally (capsule)
Experimental: 30 mg LY2409021
30 mg LY2409021 administered orally once daily for 4 weeks
Drug: LY2409021
Administered orally (capsule)
Experimental: 60 mg LY2409021
60 mg LY2409021 administered orally once daily for 4 weeks
Drug: LY2409021
Administered orally (capsule)
Experimental: 90 mg LY2409021
90 mg LY2409021 administered orally once daily for 4 weeks
Drug: LY2409021
Administered orally (capsule)

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606397

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
United Kingdom
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.
Plymouth, United Kingdom
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 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: NCT01606397     History of Changes
Other Study ID Numbers: 11071, I1R-FW-GLBB
Study First Received: May 23, 2012
Last Updated: May 23, 2012
Health Authority: Singapore: Health Sciences Authority
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on April 16, 2014