Status:
COMPLETED
Safety, Tolerability and Pharmacodynamics of CYT013-IL1bQb in Patients With Type 2 Diabetes
Lead Sponsor:
Cytos Biotechnology AG
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-69 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00924105
Start Date
June 1 2009
End Date
November 1 2011
Last Update
February 13 2012
Active Locations (3)
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1
Cytos Investigator sites
Hamburg, Germany
2
Cytos Investigator sites
Basel, Switzerland
3
Cytos Investigator sites
Zurich, Switzerland