Status:
TERMINATED
Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy
Lead Sponsor:
ConjuChem
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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.
Detailed Description
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 st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01514149
Start Date
September 1 2011
End Date
March 1 2013
Last Update
July 19 2017
Active Locations (22)
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1
Research Site
Phoenix, Arizona, United States, 85018
2
Research Site
Inglewood, California, United States, 90301
3
Research Site
Tarzana, California, United States, 91356
4
Research Site
Ventura, California, United States, 93003