Diabetes Mellitus, Type 1Phase 2NCT00278980
Effect of C-Peptide on Diabetic Peripheral Neuropathy
A Phase 2 study testing C-peptide in people with Diabetes Mellitus, Type 1 and Diabetic Polyneuropathy, run by Creative Peptides Sweden Inc. at 1 site in Sweden.
Trial summary
The aim of the study is to investigate the effect of C-peptide administration on nerve function in patients with type 1 diabetes and peripheral sensory neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetic Polyneuropathy
- What is being tested?
- C-peptide
- How many people
- 180 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2003to Dec 2004
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who have a duration of type 1 diabetes of more than 5 yrs
- Subjects who are C-peptide deficient
- Subjects who have diabetic distal symmetric neuropathy, according to the criteria defined at the San Antonio Conference on Diabetic Neuropathy 1988
- Subjects who have measurable action potential in the sural nerves
- Subjects who have reduced nerve conduction velocity in the sural nerves
Who cannot join
- Subjects who have neuropathy or signs of nerve dysfunction which may be a consequence of factors other than type 1 diabetes
- Subjects who have concomitant medication that may interfere with the peripheral nerve function or measurement thereof
- Subjects who are transplanted (islet cell, kidney or pancreas)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska University Hospital Solna
Stockholm, Stockholm County, SE-171 76
About this study
Official title: Effect of C-Peptide on Diabetic Peripheral Neuropathy, a 6 Months Randomized Double-Blind, Placebo Controlled, Dose-Finding, Multicenter Study, With Parallel Groups
The aim of the study is to investigate the effect of C-peptide administration on nerve function in patients with type 1 diabetes and peripheral sensory neuropathy.
Read the detailed description
It has been observed that C-peptide administration results in an activation of renal tubular and sciatic endoneural Na/K-ATPase of the rat and stimulation of endothelial nitric oxide synthase. The hypothesis is that C-peptide administration may improve peripheral nerve dysfunction in diabetic neuropathy by increasing nerve blood flow and Na/K-ATPase activity. The purpose of the trial is to investigate the effect of C-peptide administration on diabetic peripheral sensory neuropathy in patients with type 1 diabetes and diabetic neuropathy in the lower extremities.
- Conditions
- Diabetes Mellitus, Type 1, Diabetic Polyneuropathy
- Being tested
- C-peptide
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-peptideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sensory nerve conduction velocity from baseline to 6 mo of treatment
Secondary outcomes (3)
- Change in quantitative sensory tests and
neurological impairment assessment from baseline to 6 mo of treatment
- Safety and tolerability of C-peptide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startOct 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Double blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Creative Peptides Sweden Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lisa Juntti-Berggren, MD, PhD, Principal investigator, Karolinska University Hospital Solna, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278980
- Sponsor's protocol ID
- CPSp201
- Status last verified
- Jan 2006
- First submitted
- 12 Jan 2006
- Last updated
- 19 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of C-Peptide on Diabetic Peripheral Neuropathy, a 6 Months Randomized Double-Blind, Placebo Controlled, Dose-Finding, Multicenter Study, With Parallel Groups
- ClinicalTrials.gov ID
- NCT00278980
- Acronym / sponsor ID
- CPSp201
- Conditions
- Diabetes Mellitus, Type 1, Diabetic Polyneuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Creative Peptides Sweden Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Dec 2004
- First posted
- 19 Jan 2006 (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 aim of the study is to investigate the effect of C-peptide administration on nerve function in patients with type 1 diabetes and peripheral sensory neuropathy.
Detailed description
It has been observed that C-peptide administration results in an activation of renal tubular and sciatic endoneural Na/K-ATPase of the rat and stimulation of endothelial nitric oxide synthase. The hypothesis is that C-peptide administration may improve peripheral nerve dysfunction in diabetic neuropathy by increasing nerve blood flow and Na/K-ATPase activity. The purpose of the trial is to investigate the effect of C-peptide administration on diabetic peripheral sensory neuropathy in patients with type 1 diabetes and diabetic neuropathy in the lower extremities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects who have a duration of type 1 diabetes of more than 5 yrs
- Subjects who are C-peptide deficient
- Subjects who have diabetic distal symmetric neuropathy, according to the criteria defined at the San Antonio Conference on Diabetic Neuropathy 1988
- Subjects who have measurable action potential in the sural nerves
- Subjects who have reduced nerve conduction velocity in the sural nerves
Key exclusion criteria (3 listed)
- Subjects who have neuropathy or signs of nerve dysfunction which may be a consequence of factors other than type 1 diabetes
- Subjects who have concomitant medication that may interfere with the peripheral nerve function or measurement thereof
- Subjects who are transplanted (islet cell, kidney or pancreas)
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 |
|---|---|---|
| C-peptide | Drug | – |
Primary outcome
Change in sensory nerve conduction velocity from baseline to 6 mo of treatment
3 secondary outcomes
- Change in quantitative sensory tests and
neurological impairment assessment from baseline to 6 mo of treatment
- Safety and tolerability of C-peptide
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 19 Jan 2006.
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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.
Lisa Juntti-Berggren, MD, PhD principal investigator
Karolinska University Hospital Solna, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing C-peptide in people with Diabetes Mellitus, Type 1 and Diabetic Polyneuropathy, run by Creative Peptides Sweden Inc. at 1 site in Sweden.
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 5 inclusion and 3 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 19 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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. 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?
Change in sensory nerve conduction velocity from baseline to 6 mo of treatment. 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 19 Jan 2006.