Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus (T2DM)

In brief

DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.

Key facts

Study ID

NCT01514149

Run by

ConjuChem

People needed

73

Starts

2011-09-01

Expected to finish

2013-03-01

Last updated by the study team

2017-07-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women 18 to 70 years of age, inclusive
• 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

You may not qualify if…

• Pregnant or breastfeeding women
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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