Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes
Tracking Information
Start Date ICMJE | December 2007 |
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Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: March 23, 2009) |
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Original Primary Outcome Measures ICMJE (submitted: January 30, 2008) |
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Change History | Complete list of historical versions of study NCT00605475 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: March 23, 2009) |
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Original Secondary Outcome Measures ICMJE (submitted: January 30, 2008) |
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Descriptive Information
Brief Title ICMJE | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes |
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Official Title ICMJE | A Multi Center, Randomized, Double Blind, Placebo-controlled, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 Administered Intravenously to Patients With Type 2 Diabetes Mellitus |
Brief Summary | The purpose of this study is to evaluate, in patients with Type 2 Diabetes Mellitus, whether ACZ885 can lower HbA1c and/or peak glucose levels in response to an oral glucose tolerance test (OGTT). |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Type 2 Diabetes Mellitus |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 231 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply | ||||
Gender | Both | ||||
Ages | 18 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Germany, Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00605475 | ||||
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Responsible Party | External Affairs, Novartis | ||||
Study ID Numbers ICMJE | CACZ885A2213 | ||||
Study Sponsor ICMJE | Novartis | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Novartis |
Source: http://clinicaltrials.gov/