Diabetic Peripheral NeuropathyPhase 2NCT01681290
Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes
A Phase 2 study testing CBX129801 in people with Diabetic Peripheral Neuropathy, run by Cebix Incorporated at 29 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- CBX129801
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 29 sitesin 3 countries
- Study dates
- Oct 2012to Jan 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
29 sites in 3 countries.
29 sites in 3 countries
United States22 sites
Study site
Ann Arbor, Michigan, 48109
Study site
Atlanta, Georgia, 30318
Study site
Boston, Massachusetts, 02115
Study site
Butte, Montana, 59701
Study site
Dallas, Texas, 75230
Study site
Decatur, Georgia, 30033
Study site
Escondido, California, 92026
Study site
Fresno, California, 93720
Study site
Houston, Texas, 77030
Study site
Houston, Texas, 77074
Study site
Idaho Falls, Idaho, 83404
Study site
Irvine, California, 92618
Study site
Las Vegas, Nevada, 89102
Study site
Los Angeles, California, 90036
Study site
New York, New York, 10032
Study site
Omaha, Nebraska, 68131
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92161
Study site
San Francisco, California, 94110
Study site
Torrance, California, 90502
Study site
Tustin, California, 92780
Study site
Walnut Creek, California, 94598
Sweden5 sites
Study site
Gothenburg, 413 45
Study site
Linköping, 581 85
Study site
Malmö, 20502
Study site
Stockholm, 171 76
Study site
Umeå, 90185
Canada2 sites
Study site
Laval, Quebec, H7T 2P5
Study site
Toronto, Ontario, M5G 2C4
About this study
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
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).
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- CBX129801
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBX129801Drug
| Study group | Role | What they receive |
|---|---|---|
| CBX129801 High Dose | Experimental | Solution for injection, 2.4 mg, weekly for 52 weeks Receives: Drug: CBX129801 |
| CBX129801 Low Dose | Experimental | Solution for injection, 0.8 mg, weekly for 52 weeks Receives: Drug: CBX129801 |
| Placebo | Placebo comparator | Solution for injection, vehicle with no active, weekly for 52 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral change in sensory nerve conduction velocity
Measured: Predose and 12 months post dose
Secondary outcomes (5)
Vibration perception threshold
Measured: Predose and 6 and 12 months post dose
Clinical composite score
Measured: Predose and 6 and 12 months post dose
Pain Intensity due to DPN
Measured: Predose and 12 months post dose
Sexual function questionnaires
Measured: Predose and 6 and 12 months post dose
Quality of life questionnaire
Measured: Predose and 12 months post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cebix Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Kim, MD, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681290
- Sponsor's protocol ID
- CBX129801-DN-201
- Status last verified
- Jan 2015
- First submitted
- 5 Sep 2012
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26884473
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01681290
- Acronym / sponsor ID
- CBX129801-DN-201
- Conditions
- Diabetic Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Cebix IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBX129801 High Dose | Experimental | Drug: CBX129801Solution for injection, 2.4 mg, weekly for 52 weeks |
| CBX129801 Low Dose | Experimental | Drug: CBX129801Solution for injection, 0.8 mg, weekly for 52 weeks |
| Placebo | Placebo comparator | –Solution for injection, vehicle with no active, weekly for 52 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBX129801 | Drug | CBX129801 High Dose, CBX129801 Low Dose |
Primary outcome
Bilateral change in sensory nerve conduction velocity
Time frame: Predose and 12 months post dose
5 secondary outcomes
Vibration perception threshold
Time frame: Predose and 6 and 12 months post dose
Clinical composite score
Time frame: Predose and 6 and 12 months post dose
Pain Intensity due to DPN
Time frame: Predose and 12 months post dose
Sexual function questionnaires
Time frame: Predose and 6 and 12 months post dose
Quality of life questionnaire
Time frame: Predose and 12 months post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
- Derived from this study: PubMed 26884473Wahren 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Kim, MD
Chief Medical Officer
29 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBX129801 in people with Diabetic Peripheral Neuropathy, run by Cebix Incorporated at 29 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Sweden, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral change in sensory nerve conduction velocity (time frame: Predose and 12 months post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01681290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2015.