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

A Multi-center, Double-blind, Placebo-controlled, Randomized Study to Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes Treated With Differing Baseline Diabetes Therapies

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.

Inclusion Criteria:

1. 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

2. HbA1c between 6.5% and 8%, inclusive, at Screening; this criterion does not apply to the IGT group

3. Age from 18-74 years, inclusive, and of either sex

Exclusion Criteria:

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