Safety, Tolerability and Pharmacodynamics of CYT013-IL1bQb in Patients With Type 2 Diabetes
- Registration Number
- NCT00924105
- Lead Sponsor
- Cytos Biotechnology AG
- Brief Summary
The purpose of this clinical trial is to test safety and tolerability of a vaccine targeting Interleukin-1 beta in patients with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Diagnosis of type 2 diabetes mellitus, according to the American Diabetes Association diagnostic criteria, ≥ 3 months at time of randomization
- HbA1c in the range of 6.5 - 9.5% (inclusive) at screening
- Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 4 weeks prior to randomization
- Further criteria as defined in the clinical trial protocol
Exclusion Criteria
- Symptoms of hyperglycemia (i.e. polyuria and polydypsia)
- History of significant weight gain or loss (+/-5%) during the 4 weeks before randomization
- Fasting C-peptide level < 400 pmol/L at screening
- Change in the medicamentous treatment of elevated blood pressure, diabetes mellitus or dyslipidemia within 4 weeks prior to the randomization
- Use of any weight loss medication (over the counter prescription) or initiation of a prescribed weight management or exercise program within 4 weeks before randomization
- Current systemic anti-inflammatory therapy other than aspirin ≤ 100 mg/day or immunosuppressive treatment, in particular oral corticosteroids
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 CYT013-IL1bQb - 2 Placebo -
- Primary Outcome Measures
Name Time Method Incidence of adverse events continously
- Secondary Outcome Measures
Name Time Method Biological measures of glycemia and inflammation continously
Trial Locations
- Locations (1)
Cytos Investigator sites
🇨🇭Zuerich, Switzerland