A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus Who Are Currently on Metformin Monotherapy
- Registration Number
- NCT00638716
- Lead Sponsor
- ConjuChem
- Brief Summary
This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study.
The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients with type 2 diabetes mellitus who are currently on metformin monotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
Inclusion Criteria
- BMI: 27 to 45 kg/m2
- Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator
- Stable life-style, i.e. diet & physical activity, as determined by the Investigator
- Stable metformin daily dose ≥1000 mg for at least 3 months
- Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 CJC-1134-PC 12 weekly doses of 1.5 mg CJC-1134-PC 2 CJC-1134-PC 4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC 3 Placebo 12 weekly doses of placebo
- Primary Outcome Measures
Name Time Method Reduction of HbA1c From Baseline Screening and Day 85 Change from Baseline
- Secondary Outcome Measures
Name Time Method Reduction in FPG From Baseline Screening and Day 85 Change from Baseline
Reduction in Fasting Body Weight From Baseline Screening and Day 85 Change from Baseline
Trial Locations
- Locations (1)
ConjuChem Biotechnologies Inc.
🇨🇦Montreal, Quebec, Canada