Type 1 DiabetesPhase 1/2NCT01293461
Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes
A Phase 1/2 study testing CBX129801 in people with Type 1 Diabetes and Diabetes Mellitus, run by Cebix Incorporated at 8 sites in United States.
Trial summary
The purpose of this study is to assess safety and tolerability and determine the pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, Diabetes Mellitus, Peripheral Diabetic 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
- 72 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2011to Oct 2012
- Phase
- Phase 1/2
- 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
- Aged 18 to 55 years (Part 1), Ages 18 to 65 years (Part 2)
- Stable type 1 diabetes mellitus (T1DM) for a minimum of 5 years
- Body mass index of 18-35 kg/m2
- Be C-peptide deficient (assessed by fasting concentration level)
- Normal renal function (assessed by serum creatinine)
- Be in good general health (besides T1DM)
- Have abnormal sural nerve conduction velocity observed bilaterally (Part 2 only)
Who cannot join
- Any significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, or gastrointestinal condition or disease
- Unstable glucose control
- Have had a islet cell, kidney, and/or pancreas transplant
- Blood loss or blood donation within 56 days
- Drug or alcohol abuse (within 2 years) or recreational drug use (within 3 months)
- History or positive test result for Hepatitis B, C, and/or HIV
- Treatment with medication for peripheral neuropathy within 30 days
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Aurora, Colorado
Study site
Butte, Montana
Study site
Escondido, California
Study site
Olympia, Washington
Study site
Renton, Washington
Study site
San Antonio, Texas
Study site
Tustin, California
Study site
Walnut Creek, California
About this study
Official title: A Randomized, Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CBX129801 (Long-Acting Synthetic C-Peptide) After Subcutaneous Administration in Patients With Type 1 Diabetes Mellitus
The purpose of this study is to assess safety and tolerability and determine the pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.
Read the detailed description
This study will be conducted in two parts (Part 1 and Part 2). Part 1 will be conducted in three sequential dose cohorts with dose level escalated for each successive cohort. In Part 2 of the study, a dose regimen determined from the pharmacokinetic data from Part 1 will be administered in up to 40 additional subjects to achieve a target plasma concentration range that represents the most commonly observed physiological C-peptide levels in healthy, non-diabetic individuals.
- Being tested
- CBX129801, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBX129801Drug
Subcutaneous injection
PlaceboDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| CBX129801 | Experimental | Not described Receives: Drug: CBX129801 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the single and multiple dose pharmacokinetics of plasma CBX129801 after subcutaneous (SC) administration of CBX129801 by estimating parameters of Cmax, Tmax, Cmin, AUClast, AUCinf, Tlag, Cav, CL/F, Vz/F, and half life.
Plasma CBX129801 will be used to assess the concentration versus time profiles and PK of CBX129801.
Measured: For duration of study / 16 months
To assess the safety and tolerability of CBX129801 when administered SC by adverse events, injection site assessments, clinical laboratory tests, vital signs, physical examinations, and electrocardiograms.
Measured: For duration of study / 16 months
Secondary outcomes (4)
To evaluate the technique of sensory nerve conduction velocity (SNCV) in the sural nerves in patients with type 1 diabetes mellitus.
Measured: Predose and 6 and 12 weeks postdose
To assess the immunogenicity of CBX129801 by occurrence of anti-CBX129801 antibody formation.
Measured: For duration of study / 16 months
To evaluate the technique of motor nerve conduction velocity (MNCV) in the peroneal nerves in patients with type 1 diabetes mellitus.
Measured: Predose and 6 and 12 weeks postdose
To evaluate the technique of vibration perception threshold (VPT) in patients with type 1 diabetes (Part 2 only)
Measured: Predose and 12 weeks postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cebix Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293461
- Sponsor's protocol ID
- CBX129801-PK-101
- Status last verified
- Feb 2013
- First submitted
- 8 Feb 2011
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CBX129801 (Long-Acting Synthetic C-Peptide) After Subcutaneous Administration in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01293461
- Acronym / sponsor ID
- CBX129801-PK-101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cebix IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Feb 2011 (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 this study is to assess safety and tolerability and determine the pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.
Detailed description
This study will be conducted in two parts (Part 1 and Part 2). Part 1 will be conducted in three sequential dose cohorts with dose level escalated for each successive cohort. In Part 2 of the study, a dose regimen determined from the pharmacokinetic data from Part 1 will be administered in up to 40 additional subjects to achieve a target plasma concentration range that represents the most commonly observed physiological C-peptide levels in healthy, non-diabetic individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBX129801 | Experimental | Drug: CBX129801 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Give informed consent
- Aged 18 to 55 years (Part 1), Ages 18 to 65 years (Part 2)
- Stable type 1 diabetes mellitus (T1DM) for a minimum of 5 years
- Body mass index of 18-35 kg/m2
- Be C-peptide deficient (assessed by fasting concentration level)
Key exclusion criteria (7 listed)
- Any significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, or gastrointestinal condition or disease
- Unstable glucose control
- Have had a islet cell, kidney, and/or pancreas transplant
- Blood loss or blood donation within 56 days
- Drug or alcohol abuse (within 2 years) or recreational drug use (within 3 months)
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 |
|---|---|---|
| CBX129801Subcutaneous injection | Drug | CBX129801 |
| PlaceboSubcutaneous injection | Drug | Placebo |
Primary outcome
To assess the single and multiple dose pharmacokinetics of plasma CBX129801 after subcutaneous (SC) administration of CBX129801 by estimating parameters of Cmax, Tmax, Cmin, AUClast, AUCinf, Tlag, Cav, CL/F, Vz/F, and half life.
Time frame: For duration of study / 16 months
Plasma CBX129801 will be used to assess the concentration versus time profiles and PK of CBX129801.
To assess the safety and tolerability of CBX129801 when administered SC by adverse events, injection site assessments, clinical laboratory tests, vital signs, physical examinations, and electrocardiograms.
Time frame: For duration of study / 16 months
4 secondary outcomes
To evaluate the technique of sensory nerve conduction velocity (SNCV) in the sural nerves in patients with type 1 diabetes mellitus.
Time frame: Predose and 6 and 12 weeks postdose
To assess the immunogenicity of CBX129801 by occurrence of anti-CBX129801 antibody formation.
Time frame: For duration of study / 16 months
To evaluate the technique of motor nerve conduction velocity (MNCV) in the peroneal nerves in patients with type 1 diabetes mellitus.
Time frame: Predose and 6 and 12 weeks postdose
To evaluate the technique of vibration perception threshold (VPT) in patients with type 1 diabetes (Part 2 only)
Time frame: Predose and 12 weeks postdose
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 1 Mar 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CBX129801 in people with Type 1 Diabetes and Diabetes Mellitus, run by Cebix Incorporated at 8 sites in United States.
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 8 inclusion and 7 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 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To assess the single and multiple dose pharmacokinetics of plasma CBX129801 after subcutaneous (SC) administration of CBX129801 by estimating parameters of Cmax, Tmax, Cmin, AUClast, AUCinf, Tlag, Cav, CL/F, Vz/F, and half life. (time frame: For duration of study / 16 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2013.