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

Cytos Biotechnology

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo

Drug: CYT013-IL1bQb

Study type

Interventional

Funder types

Industry

Identifiers

CYT013-IL1bQb 01

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

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