| Trial ID: | L3048 |
| Source ID: | NCT00882726
|
| Associated Drug: |
Cnto 3649 Iv (Healthy Participants)
|
| Title: |
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CNTO 3649 in Healthy Adults and Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: CNTO 3649 IV (Healthy participants)|DRUG: CNTO 3649 SC (Healthy participants)|DRUG: CNTO 3649 SC (Diabetic patients)|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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, Week 1 to Week 5 (for healthy participants) and Week 1 to Week 8 (for diabetic patients) | Secondary: Pharmacokinetics, pharmacodynamics and immunogenicity of CNTO 3649 following single and multiple administrations., Week 1 to Week 5 (for healthy participants) and Week 1 to Week 8 (for diabetic patients)
|
| Sponsor/Collaborators: |
Sponsor: Centocor, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
133
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-02
|
| Completion Date: |
2010-04
|
| Results First Posted: |
|
| Last Update Posted: |
2013-12-16
|
| Locations: |
Miramar, Florida, United States|San Antonio, Texas, United States|Tacoma, Washington, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00882726
|
