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Sponsored by: |
ConjuChem |
---|---|
Information provided by: | ConjuChem |
ClinicalTrials.gov Identifier: | NCT00638716 |
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.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: CJC-1134-PC Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase II Study to Evaluate the Efficacy and Safety of 3 Months of Weekly Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy |
Estimated Enrollment: | 90 |
Study Start Date: | February 2008 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
12 weekly doses of 1.5 mg CJC-1134-PC
|
Drug: CJC-1134-PC
1.5 or 2.0 mg CJC-1134-PC
|
2: Experimental
4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
|
Drug: CJC-1134-PC
1.5 or 2.0 mg CJC-1134-PC
|
3: Placebo Comparator
12 weekly doses of placebo
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Drug: Placebo
Placebo
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Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Major Inclusion Criteria:
Responsible Party: | ConjuChem Biotechnologies Inc. ( Maggie Wang, MD/ Senior Director of Clinical Research ) |
Study ID Numbers: | DM200-101 |
Study First Received: | March 13, 2008 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00638716 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Type 2 Diabetes Mellitus, incretins, GLP-1, HbA1c, metformin |
Hypoglycemic Agents Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Incretins Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Glucagon-Like Peptide 1 |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Metformin Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |