Safety, Tolerability and Pharmacodynamics of CYT013-IL1bQb in Patients With Type 2 Diabetes
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
1 other identifier
interventional
48
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes-mellitus
Started Jun 2009
Longer than P75 for phase_1 type-2-diabetes-mellitus
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFebruary 13, 2012
February 1, 2012
2.4 years
June 16, 2009
February 10, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events
continously
Secondary Outcomes (1)
Biological measures of glycemia and inflammation
continously
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Cytos Investigator sites
Hamburg, Germany
Cytos Investigator sites
Basel, Switzerland
Cytos Investigator sites
Zurich, Switzerland
Related Publications (1)
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.
PMID: 26686385DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 18, 2009
Study Start
June 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
February 13, 2012
Record last verified: 2012-02