A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CNTO 3649 in Healthy Adults and Patients With Type 2 Diabetes Mellitus
NCT ID: NCT00882726
Last Updated: 2013-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
133 participants
INTERVENTIONAL
2009-02-28
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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CNTO 3649 IV (Healthy participants)
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.
Placebo
Participants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo.
CNTO 3649 SC (Healthy participants)
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.
Placebo
Participants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo.
CNTO 3649 SC (Diabetic patients)
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.
Placebo
Participants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo.
Interventions
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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.
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.
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.
Placebo
Participants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Centocor, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Centocor Clinical Trial
Role: STUDY_DIRECTOR
Centocor, Inc.
Locations
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Miramar, Florida, United States
San Antonio, Texas, United States
Tacoma, Washington, United States
Countries
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Related Links
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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.
Other Identifiers
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CNTO3649DIB1001
Identifier Type: OTHER
Identifier Source: secondary_id
CR015562
Identifier Type: -
Identifier Source: org_study_id