Symptomatic Diabetic Peripheral PolyneuropathyPhase 3NCT00483730
Actovegin® Versus Placebo in Patients With Diabetic Polyneuropathy (AV-007-IM)
A Phase 3 study testing Deproteinised hemoderivative of calf blood (Actovegin) in people with Symptomatic Diabetic Peripheral Polyneuropathy, run by Nycomed at 1 site in Denmark.
Trial summary
To assess clinical efficacy and safety of Actovegin in type 2 diabetic patients with symptomatic diabetic peripheral polyneuropathy after 250 ml i.v. infusions once daily for 20 days followed by oral treatment 600 mg × 3 daily for 140 days. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Symptomatic Diabetic Peripheral Polyneuropathy
- What is being tested?
- Deproteinised hemoderivative of calf blood (Actovegin)
- How many people
- 569 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2006to Dec 2008
- Phase
- Phase 3
- 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
- The medical condition / disease to be studied is symptomatic diabetic peripheral polyneuropathy.
- All inclusion criteria must be answered "yes" for a patient to participate in the trial.
- Has the patient given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the patient.
- Is the patient aged ≥ 18 to ≤ 65 years?
- Does the patient suffer from type 2 diabetes mellitus?
- Has the patient evidence of symptomatic diabetic peripheral polyneuropathy, i.e. TSS ≥ 6 and NIS-LL ≥ 2?
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- Is the patient's VPT measured to ≤ 30V?
- Has the patient adequate circulation to the foot as evidenced by a palpable pulse on posterior tibialis artery and dorsal artery of foot?
- Is the HbA1C level less than 10%?
- Is the patient able to make frequent clinic visits over the trial period?
- For patients receiving tricyclic antidepressants, anticonvulsants, mexiletine or neuroleptics as treatment of neuropathic pain:
- Has the regimen been stable within the last month?
- For female patients of childbearing potential (childbearing potential is considered until menopause has lasted more than 12 months):
- Does the patient use an acceptable contraceptive method (hormonal pills, patches, implants, injections or intrauterine device)?
- Is the pregnancy test negative before the 1st dose of trial medication?
- (Surgically hysterectomised and surgically successfully sterilized females may be included on the same conditions as male patients).
Who cannot join
- All exclusion criteria must be answered "no" for a patient to participate in the trial.
- Does the patient suffer from known allergy towards Actovegin or similar preparations?
- Has the patient asymmetrical neuropathy of the trunk or proximal lower limbs?
- Does the patient suffer from diabetic foot ulceration or infections?
- Does the patient suffer from diabetic amyotrophy?
- Does the patient suffer from decompensated cardiac insufficiency, pulmonary oedema, oliguria, anuria, generalised oedema?
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- Does the patient suffer from polyneuropathy due to other underlying causes?
- Has the patient been hospitalised due to diabetic polyneuropathy within the last month?
- Has the patient participated in any other trial with an Investigational Medicinal Product (IMP) or device within 30 days before inclusion in this trial?
- Has the patient ever used medications that may be etiological factors for neuropathy, such as isoniazid, nitrofurantoin, vincristine and phenytoin?
- Has the patient used cerebrolysin or α-lipoic acid or received Transcutaneous Electric Nerve Stimulation (TENS) or acupuncture within the last month?
- Has the patient received opiates as treatment of his / her diabetic polyneuropathy within the last month?
- Does the patient suffer from any malignancy?
- Is the patient nursing?
- Does the patient suffer from any mental, psychiatric or other conditions that may compromise data collection and understanding of written and verbal information given in the trial?
- Does the patient suffer from present and / or previous chronic alcohol abuse?
- Is there any anamnestic evidence of hypothyroidism?
- Is there any anamnestic evidence of vitamin B12 deficiency?
- Does the patient suffer from an impaired renal function with high blood urea nitrogen (BUN) and / or increased serum creatinine (>120 µmol/L)?
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centre, Double-blind, Placebo-controlled, Randomised, Parallel Group Clinical Trial to Evaluate Efficacy and Safety of Actovegin® in Diabetic Type 2 Patients With Symptomatic Diabetic Peripheral Polyneuropathy
To assess clinical efficacy and safety of Actovegin in type 2 diabetic patients with symptomatic diabetic peripheral polyneuropathy after 250 ml i.v. infusions once daily for 20 days followed by oral treatment 600 mg × 3 daily for 140 days.
- Being tested
- Deproteinised hemoderivative of calf blood (Actovegin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deproteinised hemoderivative of calf blood (Actovegin)Drug
Symptomatic diabetic peripheral polyneuropathy
What is being measured
The primary outcome is the main question the study is designed to answer.
TSSaverage: Average of the TSS over the treatment period (AUC / exposure time) VPTaverage: Average of the VPT measurement over the treatment period (AUC / exposure time)
Measured: Approx. 5½ months
Secondary outcomes (1)
NIS-LLaverage: Average of the NIS-LL over the treatment period (AUC / exposure time)
Measured: Approx. 5½ months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startDec 2006
- Primary completionMay 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Diabetic Peripheral PolyneuropathyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 569 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nycomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nycomced Clinical Trial Operations, Study chair, Headquaters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483730
- Sponsor's protocol ID
- AV-007-IM
- Status last verified
- May 2012
- First submitted
- 6 Jun 2007
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Double-blind, Placebo-controlled, Randomised, Parallel Group Clinical Trial to Evaluate Efficacy and Safety of Actovegin® in Diabetic Type 2 Patients With Symptomatic Diabetic Peripheral Polyneuropathy
- ClinicalTrials.gov ID
- NCT00483730
- Acronym / sponsor ID
- AV-007-IM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Jun 2007 (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.
To assess clinical efficacy and safety of Actovegin in type 2 diabetic patients with symptomatic diabetic peripheral polyneuropathy after 250 ml i.v. infusions once daily for 20 days followed by oral treatment 600 mg × 3 daily for 140 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The medical condition / disease to be studied is symptomatic diabetic peripheral polyneuropathy.
- All inclusion criteria must be answered "yes" for a patient to participate in the trial.
- Has the patient given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the patient.
- Is the patient aged ≥ 18 to ≤ 65 years?
- Does the patient suffer from type 2 diabetes mellitus?
Key exclusion criteria (19 listed)
- All exclusion criteria must be answered "no" for a patient to participate in the trial.
- Does the patient suffer from known allergy towards Actovegin or similar preparations?
- Has the patient asymmetrical neuropathy of the trunk or proximal lower limbs?
- Does the patient suffer from diabetic foot ulceration or infections?
- Does the patient suffer from diabetic amyotrophy?
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 |
|---|---|---|
| Deproteinised hemoderivative of calf blood (Actovegin)Symptomatic diabetic peripheral polyneuropathy | Drug | – |
Primary outcome
TSSaverage: Average of the TSS over the treatment period (AUC / exposure time) VPTaverage: Average of the VPT measurement over the treatment period (AUC / exposure time)
Time frame: Approx. 5½ months
1 secondary outcome
NIS-LLaverage: Average of the NIS-LL over the treatment period (AUC / exposure time)
Time frame: Approx. 5½ months
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 7 May 2012.
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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.
Nycomced Clinical Trial Operations study chair
Headquaters
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Deproteinised hemoderivative of calf blood (Actovegin) in people with Symptomatic Diabetic Peripheral Polyneuropathy, run by Nycomed at 1 site in Denmark.
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 16 inclusion and 19 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 7 May 2012. 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 Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
TSSaverage: Average of the TSS over the treatment period (AUC / exposure time) VPTaverage: Average of the VPT measurement over the treatment period (AUC / exposure time) (time frame: Approx. 5½ months). 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 7 May 2012.