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
NCT ID: NCT00638716
Last Updated: 2017-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
122 participants
INTERVENTIONAL
2008-02-29
2008-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
12 weekly doses of 1.5 mg CJC-1134-PC
CJC-1134-PC
1.5 or 2.0 mg CJC-1134-PC
2
4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
CJC-1134-PC
1.5 or 2.0 mg CJC-1134-PC
3
12 weekly doses of placebo
Placebo
Placebo
Interventions
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CJC-1134-PC
1.5 or 2.0 mg CJC-1134-PC
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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%
25 Years
ALL
No
Sponsors
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ConjuChem
INDUSTRY
Responsible Party
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Locations
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ConjuChem Biotechnologies Inc.
Montreal, Quebec, Canada
Countries
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Other Identifiers
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DM200-101
Identifier Type: -
Identifier Source: org_study_id
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