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

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