A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CNTO 3649 in Healthy Adults and Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00882726
First received: April 14, 2009
Last updated: December 13, 2013
Last verified: December 2013
  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 IV (Healthy participants)
Drug: CNTO 3649 SC (Healthy participants)
Drug: CNTO 3649 SC (Diabetic patients)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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, Pharmacodynamics, and Immune Response of CNTO 3649

Resource links provided by NLM:


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 [ Time Frame: Week 1 to Week 5 (for healthy participants) and Week 1 to Week 8 (for diabetic patients) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics, pharmacodynamics and immunogenicity of CNTO 3649 following single and multiple administrations. [ Time Frame: Week 1 to Week 5 (for healthy participants) and Week 1 to Week 8 (for diabetic patients) ] [ Designated as safety issue: No ]

Enrollment: 133
Study Start Date: February 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CNTO 3649 IV (Healthy participants) Drug: CNTO 3649 IV (Healthy participants)
Healthy participants will each receive a single dose of CNTO 3649 (1, 3, 10, 30, 100 or 300 microgram per kilogram, subject to change) as a 2-hour IV infusion.
Drug: Placebo
Participants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo.
Experimental: CNTO 3649 SC (Healthy participants) Drug: CNTO 3649 SC (Healthy participants)
Healthy participants will each receive a single dose of CNTO 3649 (10, 30, 100 or 300 microgram per kilogram, subject to change) as a SC injection.
Drug: Placebo
Participants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo.
Experimental: CNTO 3649 SC (Diabetic patients) Drug: CNTO 3649 SC (Diabetic patients)
Diabetic patients will receive multiple doses of CNTO 3649 (30, 100 or 300 microgram per kilogram, subject to change) as subcutaneous injections once weekly for 4 consecutive weeks.
Drug: Placebo
Participants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo.

Detailed Description:

This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician nor patient knows the name of the assigned study medication), ascending-dose 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 approximately 80 healthy participants (Part 1) and approximately 36 type 2 diabetic patients (Part 2). All participants will be randomized to CNTO 3649 or placebo in the ratio of 3:1. Out of 80 healthy participants, 48 participants will receive single doses of CNTO 3649 (6 dose levels) or placebo as an intravenous infusion (directly into a vein) and 32 participants will receive single doses of CNTO 3649 (4 dose levels) or placebo as a subcutaneous (under the skin) injection. All 36 diabetic patients will receive multiple doses of CNTO 3649 (3 dose levels) or placebo as subcutaneous injections. There will be a screening period of 30 days and 45 days for healthy participants and diabetes patients, respectively. 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 (healthy participants): 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 (patients with type 2 diabetes): 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 (healthy participants): Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject
  • Part 2 (patients with type 2 diabetes): 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882726

Locations
United States, Florida
Miramar, Florida, United States
United States, Texas
San Antonio, Texas, United States
United States, Washington
Tacoma, Washington, United States
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor Clinical Trial Centocor, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00882726     History of Changes
Other Study ID Numbers: CR015562, CNTO3649DIB1001
Study First Received: April 14, 2009
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014