Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes
NCT ID: NCT01681290
Last Updated: 2015-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
250 participants
INTERVENTIONAL
2012-10-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CBX129801 High Dose
Solution for injection, 2.4 mg, weekly for 52 weeks
CBX129801
CBX129801 Low Dose
Solution for injection, 0.8 mg, weekly for 52 weeks
CBX129801
Placebo
Solution for injection, vehicle with no active, weekly for 52 weeks
No interventions assigned to this group
Interventions
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CBX129801
Eligibility Criteria
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Inclusion Criteria
* 18-65 years old;
* Have type 1 diabetes mellitus for a minimum of 5 years, with a stable diabetic regimen (for at least 3 months);
* Have clinical signs of diabetic peripheral neuropathy at screening;
* Have abnormal sural nerve conduction observed bilaterally during screening;
* Be C-peptide deficient;
* Be in good general health (besides having type 1 diabetes mellitus);
* Practice effective contraception during and for at least 12 weeks after study participation;
* Have a body mass index (BMI) ≥18.0 and \<35.0 kg/m2.
Exclusion Criteria
* Unstable or inadequate glucose control;
* Any clinically significant laboratory value at screening;
* Occurrence of a severe, unexplainable hypoglycemic event (defined as requiring the assistance of another individual) within 6 months of Day 0, or recurrent episodes of non-severe hypoglycemia (≥3 per week on average) that are deemed clinically significant by the Investigator;
* Have had an islet cell, kidney, and/or pancreas transplant;
* If female, is pregnant or lactating;
* History of alcohol or substance abuse within 2 years;
* Positive screen for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibody;
* Initiation of treatment or change of dose of medication that could affect peripheral nerve function within 60 days;
* Previous treatment with CBX129801 or unmodified C-peptide;
* Receipt of an investigational product or therapeutic device, or participation in a drug research study, within a period of 30 days;
* Chronic use of oral steroids or use of Ampyra (dalfampridine) within 60 days.
18 Years
65 Years
ALL
No
Sponsors
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Cebix Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis Kim, MD
Role:
Chief Medical Officer
Locations
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Escondido, California, United States
Fresno, California, United States
Irvine, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
Torrance, California, United States
Tustin, California, United States
Walnut Creek, California, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Idaho Falls, Idaho, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Butte, Montana, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
New York, New York, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Toronto, Ontario, Canada
Laval, Quebec, Canada
Gothenburg, , Sweden
Linköping, , Sweden
Malmo, , Sweden
Stockholm, , Sweden
Umeå, , Sweden
Countries
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References
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Wahren J, Foyt H, Daniels M, Arezzo JC. Long-Acting C-Peptide and Neuropathy in Type 1 Diabetes: A 12-Month Clinical Trial. Diabetes Care. 2016 Apr;39(4):596-602. doi: 10.2337/dc15-2068. Epub 2016 Feb 16.
Other Identifiers
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CBX129801-DN-201
Identifier Type: -
Identifier Source: org_study_id