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Actovegin® Versus Placebo in Patients With Diabetic Polyneuropathy (AV-007-IM)

Primary Purpose

Symptomatic Diabetic Peripheral Polyneuropathy

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Deproteinised hemoderivative of calf blood (Actovegin)
Sponsored by
Nycomed
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Diabetic Peripheral Polyneuropathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

  1. 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.
  2. Is the patient aged ≥ 18 to ≤ 65 years?
  3. Does the patient suffer from type 2 diabetes mellitus?
  4. Has the patient evidence of symptomatic diabetic peripheral polyneuropathy, i.e. TSS ≥ 6 and NIS-LL ≥ 2?
  5. Is the patient's VPT measured to ≤ 30V?
  6. Has the patient adequate circulation to the foot as evidenced by a palpable pulse on posterior tibialis artery and dorsal artery of foot?
  7. Is the HbA1C level less than 10%?
  8. 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:

  9. 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):

  10. Does the patient use an acceptable contraceptive method (hormonal pills, patches, implants, injections or intrauterine device)?
  11. 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).

Exclusion Criteria:

All exclusion criteria must be answered "no" for a patient to participate in the trial.

  1. Does the patient suffer from known allergy towards Actovegin or similar preparations?
  2. Has the patient asymmetrical neuropathy of the trunk or proximal lower limbs?
  3. Does the patient suffer from diabetic foot ulceration or infections?
  4. Does the patient suffer from diabetic amyotrophy?
  5. Does the patient suffer from decompensated cardiac insufficiency, pulmonary oedema, oliguria, anuria, generalised oedema?
  6. Does the patient suffer from polyneuropathy due to other underlying causes?
  7. Has the patient been hospitalised due to diabetic polyneuropathy within the last month?
  8. Has the patient participated in any other trial with an Investigational Medicinal Product (IMP) or device within 30 days before inclusion in this trial?
  9. Has the patient ever used medications that may be etiological factors for neuropathy, such as isoniazid, nitrofurantoin, vincristine and phenytoin?
  10. Has the patient used cerebrolysin or α-lipoic acid or received Transcutaneous Electric Nerve Stimulation (TENS) or acupuncture within the last month?
  11. Has the patient received opiates as treatment of his / her diabetic polyneuropathy within the last month?
  12. Does the patient suffer from any malignancy?
  13. Is the patient nursing?
  14. 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?
  15. Does the patient suffer from present and / or previous chronic alcohol abuse?
  16. Is there any anamnestic evidence of hypothyroidism?
  17. Is there any anamnestic evidence of vitamin B12 deficiency?
  18. Does the patient suffer from an impaired renal function with high blood urea nitrogen (BUN) and / or increased serum creatinine (>120 µmol/L)?

Sites / Locations

  • Nycomed

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

NIS-LLaverage: Average of the NIS-LL over the treatment period (AUC / exposure time)

Full Information

First Posted
June 6, 2007
Last Updated
May 4, 2012
Sponsor
Nycomed
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1. Study Identification

Unique Protocol Identification Number
NCT00483730
Brief Title
Actovegin® Versus Placebo in Patients With Diabetic Polyneuropathy (AV-007-IM)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nycomed

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Diabetic Peripheral Polyneuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
569 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Deproteinised hemoderivative of calf blood (Actovegin)
Intervention Description
Symptomatic diabetic peripheral polyneuropathy
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
NIS-LLaverage: Average of the NIS-LL over the treatment period (AUC / exposure time)
Time Frame
Approx. 5½ months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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? 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). Exclusion Criteria: 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? 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)?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nycomced Clinical Trial Operations
Organizational Affiliation
Headquaters
Official's Role
Study Chair
Facility Information:
Facility Name
Nycomed
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark

12. IPD Sharing Statement

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Actovegin® Versus Placebo in Patients With Diabetic Polyneuropathy (AV-007-IM)

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