To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, Impaired Glucose Tolerance

In brief

This was a 10-week, placebo-controlled, randomized study to investigate the effect of injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.

Key facts

Study ID

NCT01068860

Run by

Novartis

People needed

246

Starts

2010-02-01

Expected to finish

2010-08-01

Last updated by the study team

2011-09-05

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must fulfill all criteria in one of the following groups:
• Impaired Glucose Tolerance (IGT) as diagnosed per protocol and not on an anti-diabetic medicine during the study
• Diagnosis of Type 2 diabetes in stable treatment with metformin
• Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day) in combination with a sulfonylurea
• Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day), sulfonylurea and thiazolidinedione combination therapy
• Diagnosis of Type 2 diabetes in stable treatment with at least two insulin injections a day with or without metformin
• HbA1c between 6.5% and 8%, inclusive, at Screening; this criterion does not apply to the IGT group
• Age from 18-74 years, inclusive, and of either sex

You may not qualify if…

• Type 1 diabetes or diabetes that is a result of pancreatic injury or other secondary forms of diabetes
• History or current findings of active pulmonary disease (e.g. tuberculosis, fungal diseases) as defined in the protocol:
• Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment proven.

Where it is running

• Crest Clinical Trials — Santa Ana, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Commonwealth Biomedical Research LLC — Madisonville, Kentucky, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• VA Medical Center — Omaha, Nebraska, United States
• Lillestol Research LLC — Fargo, North Dakota, United States
• Preferred Primary Care Physicians — Pittsburgh, Pennsylvania, United States
• Dallas Diabetes and Endocrine Center — Dallas, Texas, United States
• Texas Center for Drug Development P.A. — Houston, Texas, United States
• Utah Clinical Trials — Salt Lake City, Utah, United States
• Barwon Health - Geelong Hospital — Geelong, Victoria, Australia
• Austin Health - Heidelberg Repatriation Hospital — Heidelberg Heights, Victoria, Australia
• Melbourne Health - Royal Melbourne Hospital — Melbourne, Victoria, Australia
• Lifestyle Metabolism Centre (Etobicoke) — Etobicoke, Ontario, Canada
• LMC Endocrinology Centres (Markham) Ltd — Markham, Ontario, Canada
• LMC Endocrinology Centres (Thornhill) Ltd — Thornhill, Ontario, Canada
• Centre de recherche clinique de Laval — Laval, Quebec, Canada
• Hôpital Maisonneuve-Rosemont — Montreal, Quebec, Canada
• Lihavuustutkimusyksikkö — Helsinki, Finland
• Lääkärikeskus Mehiläinen Töölö — Helsinki, Finland
• ODL Terveys Oy — Oulu, Finland
• Clintrial Berlin Praxis fuer medizinische Studien — Berlin, Germany
• Klinische Forschung Berlin-Buch Dr. Andrei Khariouzov — Berlin, Germany
• Gemeinschaftspraxis Dr. Ingo Zeissig — Duisburg, Germany
• National Research Institute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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