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

NCT ID: NCT00924105

Last Updated: 2012-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-11-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

CYT013-IL1bQb

Intervention Type: DRUG

s.c. injection

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

s.c. injection

Interventions

CYT013-IL1bQb

s.c. injection

Intervention Type: DRUG

Placebo

s.c. injection

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytos Biotechnology AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cytos Investigator sites

Hamburg, , Germany

Cytos Investigator sites

Basel, , Switzerland

Cytos Investigator sites

Zurich, , Switzerland

Countries

Germany; Switzerland

References

Cavelti-Weder C, Timper K, Seelig E, Keller C, Osranek M, Lassing U, Spohn G, Maurer P, Muller P, Jennings GT, Willers J, Saudan P, Donath MY, Bachmann MF. Development of an Interleukin-1beta Vaccine in Patients with Type 2 Diabetes. Mol Ther. 2016 May;24(5):1003-12. doi: 10.1038/mt.2015.227. Epub 2015 Dec 21.

Reference Type: DERIVED

PMID: 26686385 (View on PubMed)

Other Identifiers

CYT013-IL1bQb 01

Identifier Type: -

Identifier Source: org_study_id