Type I 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 I Diabetes Mellitus
The purpose of this study is:
- to assess clinical efficacy of Subetta in the combined treatment of type I diabetes
mellitus;
- to assess safety of Subetta in the combined treatment of type I diabetes mellitus.
Patients with type I diabetes mellitus are included in the trial. It is concerned those
patients, who by the time of the trial receive basal bolus insulin therapy of type I diabetes
mellitus, including basal insulin (using long acting medications) and prandial insulin (short
and ultra short acting medications), and with poor glycemic control (HbA1c=7.0-10.0%). 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.
HbA1c, fasting plasma glucose, microalbuminuria, estimated glomerular filtration rate,
ophthalmoscopy, blood pressure measurement, patient self-monitoring of blood glucose,
frequency of hypoglycemia, endocrinologist examination were performed within screening
period. Patients without severe diabetes complications are randomized in 2 groups.
If a patient meets inclusion criteria and does not show exclusion criteria he/she is
randomized in one of 2 groups: Group 1 - patients receiving standard type I diabetes mellitus
therapy + Subetta at a dose of 1 tablet 4 times a day; Group 2 - the group receiving standard
type I diabetes mellitus therapy + Placebo under the regimen used for Subetta. The invented
names of the drugs containing basal and prandial (meal) insulin 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±1 and 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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01467063 -
Glutamine and Insulin Sensitivity in Type I Diabetes
|
N/A | |
| Completed |
NCT01552603 -
Artificial Pancreas Control System in an Inpatient Setting
|
Phase 2 | |
| Not yet recruiting |
NCT02126605 -
Accuracy of Blood Glucose Detection by Diabetes Alert Dogs
|
N/A | |
| Completed |
NCT03406000 -
Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL
|
Phase 4 |