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

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ConjuChem
• Treatments: Metformin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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