Actovegin® Versus Placebo in Patients With Diabetic Polyneuropathy (AV-007-IM)
Symptomatic Diabetic Peripheral Polyneuropathy
About this trial
This is an interventional treatment trial for Symptomatic Diabetic Peripheral Polyneuropathy
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)?
Sites / Locations
- Nycomed