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
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.
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.
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