Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGCYT013-IL1bQb
s.c. injection
DRUGPlacebo
s.c. injection
Sponsors
Cytos Biotechnology AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | continously |
Secondary
| Measure | Time frame |
|---|---|
| Biological measures of glycemia and inflammation | continously |
Countries
Germany, Switzerland
Outcome results
None listed