Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    gevokizumab cancer

Effects of XOMA 052 on Insulin Production in Type 1 Diabetes (LATE STAGE)

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.
 
ClinicalTrials.gov Identifier: NCT01788033
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : February 11, 2014
Sponsor:
Collaborator:
XOMA (US) LLC
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
To assess the effects of treatment with XOMA 052 on beta-cell function and insulin production in subjects with well-controlled Type 1 diabetes. The safety, tolerability, and pharmacokinetics (PK) of XOMA 052 will also be assessed.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Drug: XOMA 052 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well-controlled Type 1 Diabetes
Study Start Date : September 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Arm Intervention/treatment
Active Comparator: XOMA 052
0.3 mg/kg XOMA 052. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections
Drug: XOMA 052
0.3 mg/kg XOMA 052. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections

Placebo Comparator: Placebo
0.3 mg/kg placebo. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections
Drug: Placebo
0.3 mg/kg Placebo. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections




Primary Outcome Measures :
  1. C-peptide level [ Time Frame: incremental AUC over 120 minutes during the MMTT at Day 112 compared to baseline (Day 0 pre-dose ]

Secondary Outcome Measures :
  1. Change in insulin requirements [ Time Frame: 3-day average daily insulin dose at baseline (Day -3 through Day -1) compared to Day 112 (Day 109 through Day 111) ]
  2. HbA1c levels [ Time Frame: from baseline (Day 0 pre-dose) at Day 112 ]
  3. fasting glucose [ Time Frame: from baseline (Day 0 pre-dose) at Day 112 ]
  4. fasting glucagon [ Time Frame: from baseline (Day 0 pre-dose) at Day 112 ]
  5. cortisol [ Time Frame: from baseline (Day 0 pre-dose) at Day 112 ]
  6. markers of systemic inflammation (Interleukin-6, Interleukin-8, Tumor Necrosis Factor α, hs-CRP) [ Time Frame: from baseline (Day 0 pre-dose) at Day 112 ]
  7. adipokines [ Time Frame: from baseline (Day 0 pre-dose) at Day 112 ]
  8. meal-stimulated Glucagon like peptide-1 [ Time Frame: AUC over 120 minutes at Day 112 compared to baseline (Day 0 pre-dose) ]
  9. meal-stimulated gastric inhibitory polypeptide [ Time Frame: AUC over 120 minutes at Day 112 compared to baseline (Day 0 pre-dose) ]
  10. lipids profile [ Time Frame: from baseline (Day 0 pre-dose) at Day 112 ]
  11. Change in fatigue according to the Fatigue Scale for Motor and Cognitive Functions (FSMC) questionnaire [ Time Frame: from baseline at Day 112 ]
  12. Anti XOMA 052 Antibodies [ Time Frame: from baseline (Day 0 pre-dose) at Day 112 ]
  13. Number of Adverse Events [ Time Frame: from baseline (Day 0 pre-dose) at Day 364 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes (American Diabetes Association [ADA] criteria) of > 2 year duration that is judged to be stable by the investigator
  • No clinically significant change in treatment regimen for T1D (defined as a 20% change) during the 3 months prior to Screening
  • Age ≥ 18 years and ≤ 55 years
  • HbA1c < 7.5% for the previous two measurements including the measurement taken at Screening (both measurements must occur within 6 months prior to enrollment)
  • Positive glutamate decarboxylase-65 (GAD65) and/or IA-2 auto-antibodies
  • Body-mass index (BMI) > 18 and < 28 kg/m2
  • Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study
  • For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to Screening (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), double barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, and condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD), sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner), and abstinence.
  • For females receiving hormone replacement therapy (including but not limited to oral contraceptives), must have been on a stable regimen for ≥ 6 months prior to Screening. Hormone therapy must not be initiated during the study

Exclusion Criteria:

  • Signs of current infection or history of infection during the 3 months prior to Day 0
  • Known to be positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV
  • History of tuberculosis (TB) or positive PPD test. A subject who has had a positive PPD test but has completed a course of treatment for tuberculosis, had a documented vaccination against tuberculosis, or had a negative QuantiFERON®-TB test result is eligible.
  • High sensitivity C-reactive protein (hs-CRP) > 10 mg/L
  • Presence of foot, leg, or decubitus ulcers
  • Neutropenia
  • Anemia
  • Clinically significant kidney or liver disease
  • From 1 week prior to Screening, use of anti-inflammatory therapy other than aspirin ≤ 100 mg/day or up to 5 consecutive days of treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of an acute illness
  • Current immunosuppressive treatment or documented immunodeficiency
  • History of severe allergic or anaphylactic reactions
  • History of asthma requiring systemic corticosteroid therapy
  • Coronary intervention or hospitalization for cardiovascular condition within 12 months prior to Day 0
  • Uncontrolled hypertension
  • History of congestive heart failure
  • History of a coronary event within 12 months prior to Screening
  • Female subjects who are pregnant, planning to become pregnant during the course of the study, have recently delivered (within 3 month of Screening), or are breast-feeding
  • History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix or thyroid, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin
  • Receipt of a live (attenuated) vaccine within 3 months prior to Screening
  • Use of any other investigational drug within 30 days prior to enrollment or within 5 half-lives of the investigational drug, whichever is longer
  • Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to the study drug
  • Any condition (e.g., psychiatric illness) or situation that may compromise the ability of the subject to give written informed consent, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

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 ClinicalTrials.gov identifier (NCT number): NCT01788033


Locations
Layout table for location information
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University of Zurich
XOMA (US) LLC
Investigators
Layout table for investigator information
Study Chair: Marc Donath, Prof. University Hospital, Basel, Switzerland

Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01788033     History of Changes
Other Study ID Numbers: EK-189/10
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs