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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00924105
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : February 13, 2012
Information provided by (Responsible Party):
Cytos Biotechnology AG

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: CYT013-IL1bQb Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: CYT013-IL1bQb
s.c. injection
Placebo Comparator: 2 Drug: Placebo
s.c. injection

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: continously ]

Secondary Outcome Measures :
  1. Biological measures of glycemia and inflammation [ Time Frame: continously ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00924105

Cytos Investigator sites
Hamburg, Germany
Cytos Investigator sites
Basel, Switzerland
Cytos Investigator sites
Zuerich, Switzerland
Sponsors and Collaborators
Cytos Biotechnology AG

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cytos Biotechnology AG Identifier: NCT00924105     History of Changes
Other Study ID Numbers: CYT013-IL1bQb 01
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases