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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Two-Stage Randomized Placebo-controlled Ascending Dose Phase I/ IIa Study to Evaluate Safety, Tolerability, Pharmacodynamic Effects and Preliminary Efficacy of an Anti-Interleukin 1 Beta Vaccine (CYT013-IL1bQb) in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924105
• Other study ID #: CYT013-IL1bQb 01
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2009
• Last updated: February 10, 2012
• Start date: June 2009
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: Cytos Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• CYT013-IL1bQb
s.c. injection
• Placebo
s.c. injection

Locations

Country	Name	City	State
Germany	Cytos Investigator sites	Hamburg
Switzerland	Cytos Investigator sites	Basel
Switzerland	Cytos Investigator sites	Zuerich

Sponsors (1)

Lead Sponsor	Collaborator
Cytos Biotechnology AG

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		continously	Yes
Secondary	Biological measures of glycemia and inflammation		continously	No