Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT00605475

Run by

Novartis

People needed

231

Starts

2007-12-01

Expected to finish

2010-09-01

Last updated by the study team

2012-02-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arkansas Research Medical Testing — Little Rock, Arkansas, United States
• Allied Research International - Cetero Research Miami — Miami, Florida, United States
• Elite Research Institute Miami — Miami, Florida, United States
• International Research Center Towson — MD, Maryland, United States
• Covance Clinical Research Unit Inc — Portland, Oregon, United States
• Charles River Clinical Services — Northwest Tacoma, Washington, United States
• Novartis Investigator Site — Berlin, Germany
• Novartis Investigator Site — Kiel, Germany
• Novartis Investigator Site — Mönchengladbach, Germany
• Novartis Investigator Site — Munich, Germany
• Novartis Investigative Site — Neuss, Germany
• Novartis Investigative Site — Moscow, Russia
• Novartis Investigative Site — Saint Petersberg, Russia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.