Clinical trial NCT01868646
Conditions: Type II Diabetes Mellitus
Keywords: Combined Treatment of Patients With Type II Diabetes Mellitus
Sponsor: Materia Medica Holding
Start date: 2013-05-07; Completion date: 2016-06-15
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Detailed 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.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Subetta intervention 2: Placebo
Intervention descriptions: intervention 1: 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). intervention 2: 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).

Protocol documents: