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
- Conditions
- Health Condition 1: null- Diabetes Mellitus Type 2Impaired Glucose Tolerance
- Registration Number
- CTRI/2010/091/000151
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 244
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate canakinumab effects on change from baseline of meal challenge derived insulin secretion rate relative to glucose at 4 weeks for each populationTimepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method * Assess safety and tolerability for all study populationsTimepoint: 4 weeks;* Evaluate the effect on change from baseline of other meal challenge derived parameters, including insulin, glucose and other glycemic control parametersTimepoint: 4 weeks;* Provide information on canakinumab effects on improving glucose parameters in people with impaired glucose toleranceTimepoint: 4 weeks