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

NCT00882726 | Completed Phase 1

• 2 other identifiers: CR015562CNTO3649DIB1001
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; CNTO 3649; safety; Phase I; healthy adults; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (3)

CNTO 3649 IV (Healthy participants)

EXPERIMENTAL

Drug: CNTO 3649 IV (Healthy participants); Drug: Placebo

CNTO 3649 SC (Healthy participants)

EXPERIMENTAL

Drug: CNTO 3649 SC (Healthy participants); Drug: Placebo

CNTO 3649 SC (Diabetic patients)

EXPERIMENTAL

Drug: CNTO 3649 SC (Diabetic patients); Drug: Placebo

Interventions

CNTO 3649 IV (Healthy participants) DRUG

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 IV (Healthy participants)

CNTO 3649 SC (Healthy participants) DRUG

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 (Healthy participants)

CNTO 3649 SC (Diabetic patients) DRUG

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.

CNTO 3649 SC (Diabetic patients)

Placebo DRUG

Participants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo.

CNTO 3649 IV (Healthy participants); CNTO 3649 SC (Diabetic patients); CNTO 3649 SC (Healthy participants)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centocor, Inc.: lead

Study Sites (3)

Unknown Facility

Miramar, Florida, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Tacoma, Washington, United States

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Centocor Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 16, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 16, 2013

Record last verified: 2013-12

Locations

US (3)