Clinical trial NCT01681290: Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CBX129801 (Ersatta™), Long-Acting Synthetic C-Peptide, in Type 1 Diabetes Mellitus Subjects With Mild to Moderate Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Cebix Incorporated
Sponsor class: INDUSTRY
First posted: 2012-09-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the beneficial effects of CBX129801 (PEGylated synthetic human C-peptide) following weekly subcutaneous administration for 12 months in type 1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral neuropathy (DPN).


Eligibility criteria: Key Inclusion Criteria:

* Give informed consent;
* 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.

Key Exclusion Criteria:

* Any significant cardiovascular, hematological, lymphatic, immunologic, urologic, dermatologic, psychiatric, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, gastrointestinal, or other major disease;
* 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.

Primary outcomes:
measure: Bilateral change in sensory nerve conduction velocity
timeFrame: Predose and 12 months post dose
Secondary outcomes:
measure: Vibration perception threshold
timeFrame: Predose and 6 and 12 months post dose
measure: Clinical composite score
timeFrame: Predose and 6 and 12 months post dose
measure: Pain Intensity due to DPN
timeFrame: Predose and 12 months post dose
measure: Sexual function questionnaires
timeFrame: Predose and 6 and 12 months post dose
measure: Quality of life questionnaire
timeFrame: Predose and 12 months post dose
Other outcomes:
Locations:
city: Escondido
country: United States
state: California
city: Fresno
country: United States
state: California
city: Irvine
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Torrance
country: United States
state: California
city: Tustin
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Butte
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: New York
country: United States
state: New York
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Toronto
country: Canada
state: Ontario
city: Laval
country: Canada
state: Quebec
city: Göteborg
country: Sweden
city: Linköping
country: Sweden
city: Malmo
country: Sweden
city: Stockholm
country: Sweden
city: Umea
country: Sweden
Study officials:
affiliation: Chief Medical Officer
name: Dennis Kim, MD
References:
citation: 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.