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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: 2,4-thiazolidinedione; Acetohexamide; Antibodies, Monoclonal; Chlorpropamide; Glimepiride; Glipizide; Glyburide; Insulin; Insulin Lispro; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Regular, Pork; Metformin; Tolazamide; Tolbutamide; Troglitazone

Criteria

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.