Type 2 Diabetes Mellitus (T2DM) Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 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 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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