Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus

NCT01868594 | Completed Phase 4 Results

• 1 other identifier: MMH-SU-003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is:

• to assess clinical efficacy of Subetta in the combined treatment of type I diabetes mellitus;
• to assess safety of Subetta in the combined treatment of type I diabetes mellitus.

Conditions

Type I Diabetes Mellitus

Keywords

Combined treatment of patients with type I diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Changes in the Mean Value of HbA1c

  The HbA1C test was performed using a method that is certified by the National Glycohemoglobin Standardization Program (NGSP) (www.ngsp.org) and standardized or traceable to the Diabetes Control and Complications Trial (DCCT) reference assay.

  baseline and 12, 24 and 36 weeks of the treatment

Secondary Outcomes (6)

• Change in Fasting Plasma Glucose (Based on the Data of Biochemical Analysis)

  baseline and 4, 12, 24 and 36 weeks of the treatment

• Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG)

  baseline and 4, 8, 12, 18, 24, 30 and 36 weeks of the treatment

• Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides)

  baseline and 12, 24 and 36 weeks of the treatment

• Changes in Dosage of Insulin (Basal, Prandial and Total Daily Dose Insulin Measured in IU)

  baseline and 36 weeks of the treatment

• Changes in Dosage of Total Insulin Measured in IU/kg of Body Weight

  baseline and 36 weeks of the treatment

Study Arms (2)

Subetta group

EXPERIMENTAL

Patients with poor glycemic control (HbA1c=7.0-10.0%) in basal-bolus insulin regimen with a stable basal insulin dose (permissible fluctuations are ±10%) during the previous 3 months are included

Drug: Subetta

Placebo group

PLACEBO COMPARATOR

Patients with poor glycemic control (HbA1c=7.0-10.0%) in basal-bolus insulin regimen with a stable basal insulin dose (permissible fluctuations are ±10%) during the previous 3 months are included.

Drug: Placebo

Interventions

Subetta DRUG

Each Subetta tablet contains a mixture of affinity purified polyclonal antibodies to β-subunit of the rINS (6 mg) and antibodies to eNOS (6 mg) in released-active form produced by the patented technology in accordance with the applicable European Pharmacopeia requirements. Standard therapy of type I diabetes mellitus + Subetta (1 tablet 4 times a day) for 36 weeks. Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta group

Placebo DRUG

Placebo (identical to Subetta in shape and taste tablet containing exсipients). Standard therapy of type I diabetes mellitus + Placebo (1 tablet 4 times a day) for 36 weeks. Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed type I diabetes mellitus (according to WHO criteria, 1999 - 2006).
• Disease duration no less than 6 months.
• Patient's age from 18 to 65 years inclusive.
• Level of glycosylated hemoglobin 7.0- 10.0 %.
• Glomerular filtration rate ≥ 60 ml/ min/1.73m\^2.
• Stable dose of basal insulin for the last 3 months. (Permissible fluctuations are ±10%.)
• Usage of contraceptive methods by both gender patients of reproductive age during the trial and within 30 days after ending the participation in the trial.
• Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.

You may not qualify if:

• Diabetic retinopathy, preproliferative, proliferative or terminal stages (based on the results of oculist examination during screening period or 6 months prior to the trial).
• Diabetic nephropathy, proteinuria stage, chronic kidney disease on 3, 4 or 5 stage.
• Diabetic microangiopathy:
• ishemic heart disease (medical history of a sudden coronary death with successful reanimation, medical history of myocardial infarction, stable exertional angina III or IV FC; unstable angina; post-infarction cardiosclerosis; chronic heart failure III or IV FC);
• cerebrovascular diseases (medical history of acute cerebrovascular accident; progressive vascular leukoencephalopathy; vascular dementia);
• chronic obliterative peripheral vascular diseases (clinically significant);
• diabetic neuroosteoarthropathy;
• diabetic foot (clinically significant).
• Heart rhythm disorder:
• II-III atrioventricular block;
• sick sinus syndrome;
• long QT interval syndrome;
• complete left bundle branch block;
• block of 2/3 bundle branches;
• WPW syndrome;

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (15)

State Healthcare Institution of Moscow "Central research institute of gastroenterology" of Department of health care of Moscow

Moscow, 111123, Russia

Location

State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"

Moscow, 119991, Russia

Location

Nonstate Health Care Institution "Central Clinical Hospital №2 named after N.A. Semashko of Public Limited Company "Russian Railways"

Moscow, 129128, Russia

Location

Municipal budgetary authority "Khimki Central Clinical Hospital"

Moscow Region, 141400, Russia

Location

The State Budgetary Institution of Health Care of the Nizhny Novgorod Region "City clinical hospital No. 10 "

Nizhny Novgorod, 603011, Russia

Location

Nizhny Novgorod regional State Budgetary Health Institution " Nizhny Novgorod regional Clinical Hospital named after N.A. Semashko "

Nizhny Novgorod, 603126, Russia

Location

State Budgetary Educational Institution of High Professional Training "Rostov State Medical University" of Ministry of Health of Russian Federation, Department of Endocrinology

Rostov-on-Don, 344022, Russia

Location

Private company "Polyclinic Complex"

Saint Petersburg, 190013, Russia

Location

St. Petersburg State Budgetary Health Care Institution "City Polyclinic №6"

Saint Petersburg, 191482, Russia

Location

St. Petersburg State Budgetary Health Care Institution "Saint Venerable Martyr Elizaveta Municipal Hospital"

Saint Petersburg, 195257, Russia

Location

State Budgetary Educational Institution of High Professional Training "St. Petersburg State Medical University named after academician I.P. Pavlov" of Ministry of Health of Russian Federation, Therapy Faculty Board

Saint Petersburg, 197022, Russia

Location

St. Petersburg Sate Budgetary Institution "Consultative-Diagnostic Polyclinic №1 of Coastal Area"

Saint Petersburg, 197183, Russia

Location

Co.Ltd " Diabet Center"

Samara, 443067, Russia

Location

Independent Health Care Institution of Voronezh Region "Voronezh Regional Clinical Consultative-Diagnostic Center"

Voronezh, 394018, Russia

Location

State Budgetary Health Care Institution of Yaroslavl Region "Regional Сlinical Hospital"

Yaroslavl, 150062, Russia

Location

Related Publications (1)

• Mkrtumyan A, Romantsova T, Vorobiev S, Volkova A, Vorokhobina N, Tarasov S, Putilovskiy M, Andrianova E, Epstein O. Efficacy and safety of Subetta add-on therapy in type 1 diabetes mellitus: The results of a multicenter, double-blind, placebo-controlled, randomized clinical trial. Diabetes Res Clin Pract. 2018 Aug;142:1-9. doi: 10.1016/j.diabres.2018.04.044. Epub 2018 May 26.

  PMID: 29807102 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

subetta

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Michael Putilovskiy, MD, PhD, Clinical Research and Medical Information Director
• Organization: Materia Medica Holding

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: June 4, 2013
• Study Start: May 7, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 10, 2016
• Last Updated: May 30, 2019
• Results First Posted: March 4, 2019

Record last verified: 2019-05

Locations

RU (15)