Symptomatic Diabetic Peripheral Polyneuropathy
Conditions
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.
Interventions
DRUGDeproteinised hemoderivative of calf blood (Actovegin)
Symptomatic diabetic peripheral polyneuropathy
Sponsors
Nycomed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | Approx. 5½ months |
Secondary
| Measure | Time frame |
|---|---|
| NIS-LLaverage: Average of the NIS-LL over the treatment period (AUC / exposure time) | Approx. 5½ months |
Countries
Denmark
Outcome results
None listed