Effects of XOMA 052 on Insulin Production in Type 1 Diabetes

NCT01788033 | Completed Phase 2 DMC

• 1 other identifier: EK-189/10
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (1)

• C-peptide level

  incremental AUC over 120 minutes during the MMTT at Day 112 compared to baseline (Day 0 pre-dose

Secondary Outcomes (13)

• Change in insulin requirements

  3-day average daily insulin dose at baseline (Day -3 through Day -1) compared to Day 112 (Day 109 through Day 111)

• HbA1c levels

  from baseline (Day 0 pre-dose) at Day 112

• fasting glucose

  from baseline (Day 0 pre-dose) at Day 112

• fasting glucagon

  from baseline (Day 0 pre-dose) at Day 112

• cortisol

  from baseline (Day 0 pre-dose) at Day 112

Study Arms (2)

XOMA 052

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

XOMA 052 DRUG

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

XOMA 052

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• XOMA (US) LLC: collaborator

Study Sites (1)

University Hospital Basel

Basel, Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

gevokizumab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marc Donath, Prof.

  University Hospital, Basel, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 11, 2013
• Study Start: September 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

CH (1)