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

NCT01868646 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2019-05-31

Study results available
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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

Interventions

DRUG

Subetta

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).

DRUG

Placebo

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).

Sponsors & Collaborators

  • Materia Medica Holding

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-07
Primary Completion
2016-06-15
Completion
2016-06-15

Countries

  • Russia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01868646 on ClinicalTrials.gov