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

Type II Diabetes Mellitus Clinical Trial

Official title: Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type II Diabetes Mellitus

Status Completed

Clinical Trial 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.

Clinical Trial Description

Patients with type II diabetes mellitus are included in the trial. It is concerned those patients, who by the time of the trial receive basal insulin with metformin or metformin and sulfonylurea derivatives and with lack of optimal glycemic control (HbA1c>7.0%). For patients, which will be included in the trial (mainly middle aged patients without severe complications of diabetes), HbA1c>7.0% is the marker showing that optimal individual goal of glycemic control is not achieved.

If a patient meets inclusion criteria and does not show exclusion criteria he/she is randomized in one of 2 groups: Group 1 - the group receiving standard type II diabetes mellitus therapy + Subetta at a dose of 1 tablet 4 times a day; Group 2 - the group receiving standard type II diabetes mellitus therapy + Placebo under the regimen used for Subetta. The invented names of the drugs containing basal insulin, metformin and sulfonylurea derivatives used as standard type II diabetes mellitus therapy, should be unchanged for each patient during the whole trial.

All patients will receive glucometers and the appropriate glucose test strips, so they could self monitor blood glucose and register this data in their diaries.

The trial duration is 38 weeks; the main stages of the trial are conducted during screening, then in 4 weeks (Visit 2), in 12 weeks (Visit 3), in 24 weeks (Visit 4) and in 36 weeks (Visit 5). In 1 week after randomization and the onset of the trial therapy and between the visits to the study site (on weeks 8±1, 18±1and 30±1) an investigator collects data on patient's health and complaints (phone visits) to decide whether it is necessary to arrange unplanned visit to the site. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

• NCT number: NCT01868646
• Study type: Interventional
• Source: Materia Medica Holding
• Status: Completed
• Phase: Phase 4
• Start date: May 7, 2013
• Completion date: June 15, 2016