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Cytoflavin in the Treatment of Patients With Diabetic Polyneuropathy (CYLINDER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04649203
Recruitment Status : Completed
First Posted : December 2, 2020
Last Update Posted : February 7, 2022
Sponsor:
Information provided by (Responsible Party):
POLYSAN Scientific & Technological Pharmaceutical Company

Brief Summary:
One of the most common complications of diabetes mellitus is diabetic polyneuropathy, which leads to disability and reduces quality of life. The toxic effects of high glucose concentrations contribute to the formation of ketoaldehyde free radicals, which, at an increased rate of their formation, leads to the development of oxidative stress in the nervous tissue. The planned study of the use of Cytoflavin® in diabetic polyneuropathy is substantiated by its antioxidant effect, which, by analogy with alpha-lipoic acid preparations, suggests its efficacy in the combined treatment of such patients. This clinical study is being conducted to assess the efficacy and safety of Cytoflavin® versus Placebo in diabetic polyneuropathy patients with type 2 diabetes. Study patients will receive study medication, 10 IV infusions followed by 75 days of oral intake. Clinical efficacy will be assessed by alleviation of symptoms (burning, numbness, pain and pricking), using the total symptoms score(TSS), after the completion of the treatment course.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Drug: Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Multicenter, Double-blind, Placebo-controlled Randomized Clinical Trial of Efficacy and Safety of the Drug Cytoflavin®, Administered Intravenously Followed by Oral Intake, in Patients With Diabetic Polyneuropathy
Actual Study Start Date : November 25, 2020
Actual Primary Completion Date : March 29, 2021
Actual Study Completion Date : June 6, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid), 20 ml (two ampoules of 10 ml each) once a day intravenously in a dilution of 200 ml of 0.9% sodium chloride solution at a rate 3-4 ml/min, for 10 days + Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid), 2 tablets 2 times a day, for 75 days
Drug: Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)
The study drug will be administered in two phases: intravenous infusion of study drug for 10 days followed by oral administration of study drug for 75 days. Thus, the total duration of the study therapy is 12 weeks.

Placebo Comparator: Group 2
Placebo, 20 ml (two ampoules of 10 ml each) once a day intravenously in a dilution of 200 ml of 0.9% sodium chloride solution at a rate 3-4 ml / min, for 10 days + Placebo, 2 tablets 2 times a day, for 75 days
Drug: Placebo
The placebo comparator will be administered in two phases: intravenous infusion of placebo solution for 10 days followed by oral administration of placebo pills for 75 days. Thus, the total duration of the study therapy is 12 weeks.




Primary Outcome Measures :
  1. TSS (Total Symptom Score) [ Time Frame: 12 weeks ]
    Change in total TSS score at Week 12 from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent form;
  • Men and women aged 45 to 74 (inclusive);
  • Confirmed diagnosis of type 2 diabetes lasting for 1 year or more;
  • Permanent scheme of therapy (without changing doses and drugs) by oral hypoglycemic drugs and / or insulin, long-term or ultra-long (adjustment of insulin dose is possible within 10% from baseline dose) and / or agonists of glucagon-like peptide-1 receptors (GLP-1) for at least 12 weeks before screening;
  • HbA1c from 7.0 and not higher than 10.0%;
  • BMI 22-40 kg / m2;
  • Symptomatic distal sensorimotor diabetic polyneuropathy;
  • Baseline TSS (Total Syptom Score) ˃5 points;
  • Score ≥2 by at least one of the TSS symptoms;
  • The severity of pain by the corresponding TSS subscale ≤ 2;
  • NISLL (Neuropathy Impairment Score Low Limbs) ≥ 2 points;
  • Patient consent to use adequate contraceptive methods for the entire study;
  • Consent to maintain a stable diet, exercise, therapy and diabetes control throughout the study;
  • Ability to comply with all protocol requirements.

Exclusion Criteria:

  • Pregnant or lactating women, or women planning a pregnancy during a clinical trial;
  • Type 1 diabetes and other specific types of diabetes;
  • Acute metabolic complications of diabetes such as ketoacidosis or hyperosmolar state within 6 months prior to screening;
  • Therapy with short and ultra-short insulin within 3 months before screening;
  • Fasting plasma glucose at screening> 15 mmol / l;
  • The presence of severe complications of diabetes;
  • Epilepsy, epileptiform seizures, head trauma with loss of consciousness, tumor, inflammatory and demyelinating diseases of the central nervous system;
  • Diseases requiring prior or current treatment by systemic corticosteroid drugs, cytostatics or penicillamine;malignant neoplasms within the last 5 years (excluding basal cell carcinoma);
  • Cardiovascular diseases in the stage of decompensation at present or within 3 months before screening;
  • Uncontrolled arterial hypertension with systolic arterial pressure> 180 mm Hg and diastolic blood pressure> 110 mm Hg at screening;
  • Nephrotic syndrome, severe chronic renal failure or significant kidney disease with a level of glomerular filtration rate (GFR) <30 ml / min;
  • Active viral (hepatitis B and C) or cirrhotic liver disease; increased aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) 3 times from upper normal limit; increased total bilirubin 2 times from upper normal limit;
  • HIV; a severe infectious disease within 30 days before screening;
  • Anemia (hemoglobin ≤ 105 g / l in women or ≤ 115 g / l in men); acute blood loss or donation of at least one unit of blood (500 ml) or blood transfusion within the previous 12 weeks;
  • Drug or alcohol abuse;
  • Intake of Cytoflavin® for 3 months before screening;
  • Known allergies, hypersensitivity or contraindications to the drug Cytoflavin® or its components;
  • Intake of alpha-lipoic acid, thiamine derivatives, pyridoxine, cyanocobalamin (excluding multivitamins), antidepressants and derivatives of gabapentin within 3 months before screening;
  • Use of other investigational drugs within 3 months prior to screening;
  • Inability to read or write; unwillingness to understand and follow protocol procedures; non-compliance with the protocol requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649203


Locations
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Russian Federation
City Clinical Hospital n.a. V.P.Demikhov
Moscow, Russian Federation
City Clinical Hospital n.a.M.E.Zhadkevitch
Moscow, Russian Federation
City Clinical Hospital #13 Avtozavodsky district
Nizhny Novgorod, Russian Federation
Research Center for Eco-safety, Ltd.
Saint Petersburg, Russian Federation, 196143
"Astarta" Ltd.
Saint Petersburg, Russian Federation
City General Hospital №2
Saint Petersburg, Russian Federation
City Outpatient Clinic #51
Saint Petersburg, Russian Federation
I. P. Pavlov 1st St. Petersburg State Medical University
Saint Petersburg, Russian Federation
North-West State Medical University named after I.I. Mechnikov
Saint Petersburg, Russian Federation
"Consultative and diagnostic center with a polyclinic" of the Administrative Department of the President of the Russian Federation
Saint-Petersburg, Russian Federation
Almazov National Medical Research Centre
Saint-Petersburg, Russian Federation
City Outpatient Clinic #117
Saint-Petersburg, Russian Federation
MEDICA Ltd.
Saint-Petersburg, Russian Federation
"Diabetes" medical center
Samara, Russian Federation
Saratov State Medical University n.a. V.I.Razumovsky
Saratov, Russian Federation
GBUZ YAO "Regional Clinical Hospital"
Yaroslavl, Russian Federation
Sponsors and Collaborators
POLYSAN Scientific & Technological Pharmaceutical Company
Investigators
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Study Chair: Igor A Strokov, Prof. "First Moscow State Medical University n.a. I.M.Sechenov of the Ministry of Health of Russia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: POLYSAN Scientific & Technological Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT04649203    
Other Study ID Numbers: CTF-III-DM-2019
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by POLYSAN Scientific & Technological Pharmaceutical Company:
Diabetes Mellitus
Peripheral Nervous System Diseases
Antioxidants
Succinic acid
Additional relevant MeSH terms:
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Diabetic Neuropathies
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Riboflavin
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents