Safety, Tolerability and Pharmacodynamics of CYT013-IL1bQb in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cytos Biotechnology AG

Criteria

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