CTRI/2010/091/000151RecruitingPhase 2
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
ovartis Healthcare Private Limited0 sites244 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 244
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
Investigators
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