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

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00483730
First received: June 6, 2007
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Symptomatic Diabetic Peripheral Polyneuropathy
Drug: Deproteinised hemoderivative of calf blood (Actovegin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Nycomed:

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) [ Time Frame: Approx. 5½ months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • NIS-LLaverage: Average of the NIS-LL over the treatment period (AUC / exposure time) [ Time Frame: Approx. 5½ months ] [ Designated as safety issue: Yes ]

Enrollment: 569
Study Start Date: December 2006
Study Completion Date: December 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Deproteinised hemoderivative of calf blood (Actovegin)
    Symptomatic diabetic peripheral polyneuropathy
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  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)?
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483730

Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nycomed
Investigators
Study Chair: Nycomced Clinical Trial Operations Headquaters
  More Information

No publications provided

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00483730     History of Changes
Other Study ID Numbers: AV-007-IM
Study First Received: June 6, 2007
Last Updated: May 4, 2012
Health Authority: Kazakhstan: Ethical Commission
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health

Additional relevant MeSH terms:
Polyneuropathies
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Actovegin
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Radiation-Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014