Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose tolerance test (OGTT). |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Canakinumab Drug: Placebo Drug: Metformin |
Phase | Phase 2 |
Sponsor | Novartis |
Responsible Party | Novartis |
ClinicalTrials.gov Identifier | NCT00605475 |
First Received | January 18, 2008 |
Last Updated | January 10, 2012 |
Last verified | January 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | January 18, 2008 |
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Last Updated Date | January 10, 2012 |
Start Date | December 2007 |
Estimated Primary Completion Date | September 2010 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes |
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Official Title | 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 was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose tolerance test (OGTT). |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Canakinumab Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg. Other Names: ACZ885Drug: Placebo Placebo to Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg. Other Names: PlaceboDrug: Metformin Participants continued on their stable daily dose of metformin throughout the study Other Names:
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Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 231 |
Estimated Completion Date | September 2010 |
Estimated Primary Completion Date | September 2010 |
Eligibility Criteria | Inclusion Criteria: - Male or female patients aged 18 to 70 years, with type 2 diabetes mellitus (non-insulin dependent diabetes) for at least 6 months prior to study start - HbA1c between 7.0 and 9.5% - On stable dose metformin monotherapy - Stable body weight Exclusion Criteria: - Poorly controlled type 2 diabetes (very low or very high blood sugar levels, or other indicators of poor control) - Acute infections prior to dosing - Patients with type 1 diabetes (insulin-dependent diabetes) - Taking diabetes medication (other than metformin) Other protocol-defined inclusion/exclusion criteria may apply |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Germany, Russian Federation |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00605475 |
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Other Study ID Numbers | CACZ885A2213 |
Has Data Monitoring Committee | No |
Information Provided By | Novartis |
Study Sponsor | Novartis |
Collaborators | Not Provided |
Investigators | Principal Investigator: NOVARTIS Novartis investigator site |
Verification Date | January 2012 |
Locations[ + expand ][ + ]
Arkansas Research Medical Testing | Little Rock, Arkansas, United States, 72202 |
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Allied Research International - Cetero Research Miami | Miami, Florida, United States, 33169 |
Elite Research Institute Miami | Miami, Florida, United States, 33169 |
International Research Center Towson | MD, Maryland, United States, 21286 |
Covance Clinical Research Unit Inc | Portland, Oregon, United States, 97239 |
Charles River Clinical Services | NW Tacoma, Washington, United States, 98418 |
Novartis Investigator Site | Berlin, Germany |
Novartis Investigator Site | Kiel, Germany |
Novartis Investigator Site | Moenchengladbach, Germany |
Novartis Investigator Site | Munich, Germany |
Novartis Investigative Site | Neuss, Germany |
Novartis Investigative Site | Moscow, Russian Federation |
Novartis Investigative Site | St. Petersberg, Russian Federation |