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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00924105
First received: June 16, 2009
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: CYT013-IL1bQb
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Cytos Biotechnology AG:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: continously ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biological measures of glycemia and inflammation [ Time Frame: continously ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: June 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: CYT013-IL1bQb
s.c. injection
Placebo Comparator: 2 Drug: Placebo
s.c. injection

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924105

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

No publications provided

Responsible Party: Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT00924105     History of Changes
Other Study ID Numbers: CYT013-IL1bQb 01
Study First Received: June 16, 2009
Last Updated: February 10, 2012
Health Authority: Germany: Paul-Ehrlich-Institut
Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on July 31, 2014