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

This is an interventional supportive care trial for Type II Diabetes Mellitus focused on measuring Combined Treatment of Patients With Type II Diabetes Mellitus Read More

Inclusion Criteria:

1. Diagnosed type II diabetes mellitus (according to WHO criteria, 1999 - 2006).
2. Patient's age from 18 to 65 years inclusive.
3. Level of glycosylated hemoglobin 7.0- 10.0 %.
4. Dose of basal insulin ≥10 units/day combined with metformin or with metformin and sulfonylurea derivatives during not less than 3 months prior to inclusion in the trial.
5. Body mass index ≥25.0 and ≤40.0kg/m^2.
6. Constant body weight (without fluctuations > 10% during not less than 3 months prior to inclusion in the trial).
7. Glomerular filtration rate ≥ 60 ml/ min/1.73m^2.
8. Stable dose of basal insulin for the last 3 months.(Permissible fluctuations are ±10%.)
9. Usage of contraceptive methods by both gender patients of reproductive age during the trial and within 30 days after ending the participation in the trial.
10. Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.

Exclusion Criteria:

1. Acute diabetes mellitus complications for 3 months prior to inclusion in the trial (diabetic ketoacidosis, hyperosmolar hyperglycemic state, lacticemia, severe hypoglycemia and hypoglycemic coma).
2. Diabetic retinopathy, preproliferative, proliferative or terminal stages (based on the results of oculist examination during screening period or 6 months prior to the trial).
3. Diabetic nephropathy, proteinuria stage, chronic kidney disease on 3, 4 or 5 stage.

4. Diabetic microangiopathy:

   • ishemic heart disease (medical history of a sudden coronary death with successful reanimation, medical history of myocardial infarction, stable exertional angina III or IV FC; unstable angina; postinfarction cardiosclerosis; chronic heart failure III or IV FC);
   • cerebrovascular diseases (medical history of acute cerebrovascular accident; progressive vascular leukoencephalopathy; vascular dementia);
   • chronic obliterative peripheral vascular diseases (clinically significant);
   • diabetic neuroosteoarthropathy;
   • diabetic foot (clinically significant).

5. Heart rhythm disorder:

   • II-III atrioventricular block;
   • sick sinus syndrome;
   • long QT interval syndrome;
   • complete left bundle branch block;
   • block of 2/3 bundle branches;
   • WPW syndrome;
   • ventricular arrhythmia of III grade according Laun-Wolf;
   • paroxysmal supraventricular tachycardia;
   • paroxysmal/recurrent ventricular tachycardia;
   • atrial flutter and fibrillation;
   • ventricular flutter and fibrillation;
   • heart pacemaker implant.
6. Uncontrolled arterial hypertension characterized by the following blood tension values: systolic blood pressure over 160 mm Hg and/or diastolic blood pressure over 100 mm Hg.
7. Severe concomitant pathology including clinically significant cardio- vascular diseases of III - IV functional class (according to New York Heart Association classification, 1964), nervous and endocrine system diseases, including morbid obesity (body mass index≥40.0 kg/m^2), renal insufficiency, liver failure.
8. Medical history of pancreatectomy or transplantation of pancreatic/islet cells.
9. Medical history of renal transplantation.
10. Malignant neoplasms/suspected malignant neoplasms.
11. Exacerbations or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial.
12. The results of analysis of liver enzymes (alanine aminotransferase, aspartate aminotransferase) more than threefold exceeding of upper limit of normal values.
13. Level of fasting triglycerides >5.64 mmol/L.
14. Medical history of bariatric surgical operations.
15. Medical history of polyvalent allergy
16. Allergy/ intolerance to any of the components of medications used in the treatment.
17. Intake of medicines listed in the section "Prohibited concomitant treatment" for 3 months prior to the inclusion in the trial.
18. Pregnancy, breast-feeding.
19. Drug addiction, alcohol usage in the amount exceeding 2 units of alcohol per day.
20. Mental disorders of a patient.
21. Night work.
22. Participation in other clinical trials in the course of 3 months prior to the inclusion in the trial.
23. Patients, who from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
24. Other factors impeding patient's participation in the trial (for example, planned business trips or journeys).
25. Patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the researcher. The immediate relative includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
26. Patient works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or appointed official responsible for the carrying out the research) or the immediate relative.