Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy
NCT ID: NCT01514149
Last Updated: 2017-07-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
73 participants
INTERVENTIONAL
2011-09-30
2013-03-31
Brief Summary
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Detailed Description
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Patients with T2DM, who meet all the inclusion criteria and none of the exclusion criteria, will be randomly assigned to a treatment arm. All patients will undergo weekly clinic visits to receive 17 weeks of study treatment, including the titration period.
CJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state. Patients will be closely monitored and evaluated for toxicity on an ongoing basis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1 - Weekly CJC-1134-PC
CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
Arm 2 - Weekly CJC-1134-PC
CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
Arm 3 - Weekly CJC-1134-PC
CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
Arm 4 - Weekly CJC-1134-PC
CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
Arm 5 - Weekly Placebo
Weekly placebo for CJC-1134-PC Injection
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
Interventions
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CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
Weekly placebo for CJC-1134-PC Injection
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index of 27 to 45 kg/m2
* Diagnosed with T2DM for at least 6 months before screening
* Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
* FPG ≤240 mg/dL at screening
* HbA1c ≥7.0% and ≤11% at screening
* A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval
Exclusion Criteria
* Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
* Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
* Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
* Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
* Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening
18 Years
70 Years
ALL
No
Sponsors
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ConjuChem
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick Soon-Shiong, MD
Role: STUDY_DIRECTOR
Chief Executive Officer
Robert Henry, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
Inglewood, California, United States
Research Site
Tarzana, California, United States
Research Site
Ventura, California, United States
Research Site
Wellington, Florida, United States
Research Site
Idaho Falls, Idaho, United States
Research Site
Lexington, Kentucky, United States
Research Site
Brighton, Massachusetts, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Eugene, Oregon, United States
Research Site
Altoona, Pennsylvania, United States
Research Site
East Providence, Rhode Island, United States
Research Site
Charleston, South Carolina, United States
Research Site
Taylors, South Carolina, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Henrico, Virginia, United States
Research Site
Vancouver, British Columbia, Canada
Research Site
Smiths Falls, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Countries
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Other Identifiers
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DM200-103
Identifier Type: -
Identifier Source: org_study_id
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