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.
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 (T2DM) on metformin monotherapy. This study will be a randomized, double-blind comparison of CJC-1134-PC versus placebo. Patients taking metformin will continue to take their metformin at the same dose for the duration of the study. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
73
CJC-1134-PC administered weekly by subcutaneous injection
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
Research Site
Phoenix, Arizona, United States
Research Site
Inglewood, California, United States
Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18
Time frame: CFB to Week 18
Fasting Body Weight CFB to Week 18
Time frame: CFB to Week 18
Time to Hyperglycemia Rescue
Time frame: 18 weeks
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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
...and 12 more locations