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A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CNTO 3649 in Healthy Adults and Patients With Type 2 Diabetes Mellitus
This study is currently recruiting participants.
Verified by Centocor, Inc., April 2009
First Received: April 14, 2009   Last Updated: April 30, 2009   History of Changes
Sponsored by: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00882726
  Purpose

The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTO 3649 following a single dose in healthy adults and following multiple doses in patients with Type 2 Diabetes Mellitus.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: CNTO 3649; Placebo
Phase I

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Single Group Assignment, Safety Study
Official Title: A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Intravenous and Subcutaneous Single-Dose Study in Healthy Subjects and Ascending Subcutaneous Multiple-Dose Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmaco

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of a single IV or SC administration of CNTO 3649 in healthy participants; Safety and tolerability of multiple SC injections of CNTO 3649 in Type 2 Diabetic Patients

Secondary Outcome Measures:
  • Pharmacokinetics, pharmacodynamics and immunogenicity of CNTO 3649 following single and multiple administrations.

Estimated Enrollment: 116
Study Start Date: February 2009
Detailed Description:

This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician or patient knows the name of the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of CNTO 3649. The study population will consist of 80 healthy participants and 36 type 2 diabetic patients. Six dose levels of study agent will be assessed. Participants will be required to stay at the research center after study agent administration for the inpatient portion of the study and then return for out-patient visits.

Placebo (containing inactive substances only) or one of six dose levels of CNTO 3649 will be given. Healthy subjects will be given a single IV infusion (directly into a vein) or a single dose of up to 2 injections under the skin. Diabetic patients will be given 4 doses as up to 2 injections under the skin (SC) over 4 weeks. There will be a screening period of up to 30 days. Healthy participants will be in the study for 9 weeks. Diabetic patients will be in the study for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Part 1: Demonstrate an understanding of the study and sign an informed consent form
  • Healthy male or female subjects with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments including complete blood count, coagulation tests, urinalysis, measurement of vital signs, and ECG
  • Age 18 to 55
  • Have a body mass index (BMI) of 18.5 to 30 kg/m2 and weight of 50 to 100 kg
  • Part 2: Type 2 Diabetic male or female subjects diagnosed at least 12 months prior to screening and are stably managed for >= 3 months
  • HbA1c levels within the range of 6% to 10% if being treated with diet and exercise alone, and 6% to 9% if on therapy
  • BMI 18.5 to 37 kg/m2. Age 18 to 65 years

Exclusion Criteria:

  • Part 1: Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject
  • Part 2: Any clinically significant medical illness or medical disorders (with the exception of diagnosis of T2DM, well-controlled hypertension, or well-controlled dyslipidemia) the investigator considers should exclude the subject. History of more than 3 days of insulin use in the last 3 months, or any thiazolidinedione medications, any alpha glucosidase inhibitors, or exenatide within 3 months of the screening visit. History of clinically significant acute or chronic diabetic complications. History of severe hypoglycemic reaction in the 6 months prior to the screening visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882726

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com

Locations
United States, Florida
Recruiting
Miramar, Florida, United States, 33025
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Additional Information:
No publications provided

Study ID Numbers: CR015562
Study First Received: April 14, 2009
Last Updated: April 30, 2009
ClinicalTrials.gov Identifier: NCT00882726     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Type 2 Diabetes Mellitus
CNTO 3649
Phase I
healthy adults
safety

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Healthy
Glucose Metabolism Disorders
Metabolic Disorder

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

ClinicalTrials.gov processed this record on May 06, 2009