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

NCT01868646 | Completed Phase 4 Results

• 1 other identifier: MMH-SU-004
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 17

Brief Summary

The purpose of this study is:

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

Conditions

Type II Diabetes Mellitus

Keywords

Combined Treatment of Patients With Type II 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.

  In 12, 24 and 36 weeks of the treatment as compared to the baseline

Secondary Outcomes (10)

• Change in Fasting Plasma Glucose

  In 4, 12, 24 and 36 weeks of the treatment as compared to the baseline

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

  During the whole study period (on weeks 4, 8, 12, 18, 24, 30 and 36 of the treatment) as compared to the baseline

• Mean Value of C-peptide

  In 12, 24 and 36 weeks of the treatment as compared to the baseline

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

  In 12, 24 and 36 weeks of the treatment as compared to the baseline

• Changes in Dosage of Insulin (Basal Dose Insulin Measured in IU/Day)

  In 36 weeks of the treatment as compared to the baseline

Study Arms (2)

Subetta

EXPERIMENTAL

Drug: Subetta

Placebo

PLACEBO COMPARATOR

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 II 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

Placebo DRUG

Placebo (identical to Subetta in shape and taste tablet containing exсipients). Standard therapy of type II 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

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 II diabetes mellitus (according to WHO criteria, 1999 - 2006).
• Patient's age from 18 to 65 years inclusive.
• Level of glycosylated hemoglobin 7.0- 10.0 %.
• Body mass index ≥25.0 and ≤40.0kg/m\^2.
• 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; postinfarction 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 (17)

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

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

Nizhny Novgorod Region, 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

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

Saint Petersburg, 191482, Russia

Location

St. Petersburg State Budgetary Health Care Institution "City Polyclinic №77 of Nevsky District", The City Diabetes Center №4

Saint Petersburg, 192177, 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

St. Petersburg State Budgetary Health Care Institution "Consultative-Diagnostic Center № 85", Diabetes Center №2

Saint Petersburg, 198260, Russia

Location

Co.Ltd " Diabet Center"

Samara, 443067, Russia

Location

The State Budgetary Educational Institution of Higher Professional Education "Smolensk National Research Medical University" Ministry of Health of the Russian Federation

Smolensk, 214019, Russia

Location

Vladimir region State budgetary institution of health care "Regional clinical hospital"

Vladimir, 600023, 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

subetta

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: June 15, 2016
• Study Completion: June 15, 2016
• Last Updated: May 31, 2019
• Results First Posted: March 4, 2019

Record last verified: 2019-05

Locations

RU (17)