Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2)
NCT ID: NCT00977483
Last Updated: 2022-02-07
Study Results
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Basic Information
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COMPLETED
PHASE3
460 participants
INTERVENTIONAL
1998-05-31
2005-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Drug: Thioctic Acid
600mg tablet Thioctic Acid (alpha-lipoic acid) once daily throughout the trial
Thioctic Acid
600mg tablet once daily 4 years double-blind treatment period
Drug: Placebo
1 tablet once daily throughout the trial
Placebo
1 tablet once daily 4 years double-blind treatment period
Interventions
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Thioctic Acid
600mg tablet once daily 4 years double-blind treatment period
Placebo
1 tablet once daily 4 years double-blind treatment period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diabetes mellitus (Type I or II), as defined by the American Diabetes Association 1997, lasting \> 1 year
3. Males or females 18 to 64 years (older patients are excluded because of age-related changes in reflexes, quantitative sensory testing endpoints, and nerve conduction endpoints)
4. Patient must have a symmetric sensory-motor peripheral polyneuropathy attributable to diabetes mellitus following a thorough evaluation for other causes of neuropathy determined by performing complete medical and neurological examinations including physical and neurological history, history of medications, history of exposure to other toxins, and laboratory studies
5. Severity of diabetic polyneuropathy must be Stage 1 or 2a
6. Insulin regimen, weight, diet, and activity level must be relatively stable in the opinion of the investigator (for example, HbA1C must not vary by more than ± 2 Vol.% within 6 months preceding the study i.e. if the index measure = 10% the range would be 8-12%)
7. NIS\[LL\]+7 tests ≥ 97.5 percentiles (corresponding to 4.43 transformed score points)
8. NIS\[LL\] ≥ 2 points (NIS\[LL\] is based on questions 17-24, 28, 29, 34, 35, and 37 of the NIS)
9. One of the following:
* an abnormality of nerve conduction attributes in two separate nerves, i.e. ≥99th percentile for DL or ≤1st percentile for NCV or amplitude or
* an abnormality of HRDB, i.e. ≤ 1st percentile
10. TSS (feet) ≤5
11. Females must either be surgically sterilised (tubal ligation, bilateral oophorectomy, or hysterectomy) or at least 1 year postmenopausal or practicing an acceptable method of contraception, including oral contraceptives with a stable regimen for at least two months, depo-medroxyprogesterone, a barrier method alone (diaphragm, condoms, or contraceptive sponge with spermicidals), or an IUD that has been in place for at least two months
Exclusion Criteria
2. Neuropathy of any cause other than diabetes mellitus which might interfere with the assessment of the severity of dPNP Other neurologic diseases that may produce weakness, sensory loss, or autonomic symptoms or test abnormality which might interfere with the assessment of the severity of dPNP Myopathy of any cause which might interfere with the assessment of the severity of dPNP
3. Peripheral vascular disease severe enough to cause intermittent claudication or ischemic ulcers or limb ischemia
4. Patients with a history of ophthalmological findings suggesting a high risk for visual loss i.e., significant maculopathy or proliferative retinopathy
5. Psychiatric, psychological, or behavioural symptoms that would interfere with the patient's ability to participate in the trial
6. Patients with any active neoplastic disease except basal cell carcinoma
7. Patients with atrial fibrillation unless controlled and stabilised by medication (changed to this criterion by Amendment 1)
8. Patients with clinically significant cardiac, pulmonary, gastrointestinal, hematologic, or endocrine disease (other than diabetes) that may confound interpretation of the study results or prevent the patient from completing the study
9. Patients who have had organ transplants of any kind
10. Patients with significant hepatic or renal disease (ASAT or ALAT \>2 times normal, serum creatinine \>1.8 mg/dL (\>159 µmol/l) for males or \>1.6 mg/dL (\>141 µmol/l) for females)
11. Patients with a recent history (within last 12 months) of drug or alcohol abuse
12. Use of any investigational drug within the last 6 months
13. History of severe or anaphylactic reaction to multiple drugs, sulfur products, or biologic products (changed to this criterion by Amendment 1)
14. Ketoacidosis or hypoglycaemia within last 3 months resulting in hospital admission
15. Antioxidant therapy (vitamins E \> 400IU, C \> 200mg, and beta-Carotene \> 30mg) or pentoxyphylline within last 1 month before start of trial
16. Use of evening primrose oil or any other gamma-linolenic acid containing substance within the last 3 months
17. Use of thioctic acid \> 50mg/day within last 3 months
18. History of use of medications or vitamins known to cause peripheral neuropathy including but not limited to use of phenytoin or carbamazepine over 15 or more years, or use of pyridoxine \> 100mg/d within the past 12 months
19. Bilateral sural nerve biopsies
20. Existing foot ulcers
21. Pregnant or lactating females
22. Continued use of medications listed in protocol 6.3.3 (first paragraph)
23. Medication non-compliance (deviation of more than ±10% of dosages to be taken (1 tablet/day))
18 Years
64 Years
ALL
No
Sponsors
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Clinquest, Inc.
INDUSTRY
Ergomed
INDUSTRY
Quintiles, Inc.
INDUSTRY
MEDA Pharma GmbH & Co. KG
INDUSTRY
Responsible Party
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MEDA Pharma GmbH & Co. KG
Principal Investigators
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Peter James Dyck
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic, Dept. of Neurology, 200 First Street Southwest, Rochester, MN 55905, USA
Locations
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´Diabetes Care Center
Birmingham, Alabama, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Medical Building
Long Beach, California, United States
UCSD Neuromuscular Research Program
San Diego, California, United States
University of California
San Francisco, California, United States
Diabetes Research Center
Tustin, California, United States
Loyola University Medical Center
Maywood, Illinois, United States
Beth Israel Medical Center
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Health Partners Riverside Neurology Clinic
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Missouri Dept. of Neurology
Columbia, Missouri, United States
Creighton University Diabetes Center
Omaha, Nebraska, United States
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, United States
Ney York Hospital Cornell Med Center
New York, New York, United States
East Carolina University, School of Medicine
Greenville, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States
University of Texas South Western Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Diabetes & Glandular Disease Center
San Antonio, Texas, United States
Leonard R. Strelitz Diabetes Institutes
Norfolk, Virginia, United States
University Clinic for Diabetes, Endocrinology and Metabolic
Zagreb, , Croatia
University Clinic of Internal Medicine
Zagreb, , Croatia
University Hospital
Hvidovre, , Denmark
Hospital Jean Verdler
Bondy, , France
Policlinic University
Napoli, , Italy
Hospital Geriatrico Diabetological Service
Padua, , Italy
Hosptal of Parma Department of Medicine
Parma, , Italy
University Hospital Utrecht Department of Internal Medicine
Utrecht, , Netherlands
Hospital del Mar Department Neurophysiology
Barcelona, , Spain
Hospital Clinico y Provincial
Barcelona, , Spain
C.H.U.S. General Hospital
Santiago de Compostela, , Spain
University Clinic
Malmo, , Sweden
Manchester Royal Infirmary Department of Medicine
Manchester, , United Kingdom
Countries
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References
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Ziegler D, Low PA, Litchy WJ, Boulton AJ, Vinik AI, Freeman R, Samigullin R, Tritschler H, Munzel U, Maus J, Schutte K, Dyck PJ. Efficacy and safety of antioxidant treatment with alpha-lipoic acid over 4 years in diabetic polyneuropathy: the NATHAN 1 trial. Diabetes Care. 2011 Sep;34(9):2054-60. doi: 10.2337/dc11-0503. Epub 2011 Jul 20.
Other Identifiers
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NATHAN1
Identifier Type: -
Identifier Source: secondary_id
D-20557/9353000001
Identifier Type: -
Identifier Source: secondary_id
D-20557-3011
Identifier Type: -
Identifier Source: org_study_id
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