<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03804411</url>
  </required_header>
  <id_info>
    <org_study_id>11/2017</org_study_id>
    <nct_id>NCT03804411</nct_id>
  </id_info>
  <brief_title>Prognostic Predictors of Response to Hypoglycemic Therapy</brief_title>
  <official_title>Search for Highly Specific Predictors of Response to Different Hypoglycemic Therapy for Cardiovascular Prognosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled trial aimed to determine highly specific personified&#xD;
      predictors of response to the therapy by different groups of hypoglycemic drugs (SGLT-2&#xD;
      inhibitors, DPP-4 inhibitors, GLP-1 receptor agonists, sulfonylureas) in patients with type 2&#xD;
      diabetes mellitus, develop an algorithm of personalized therapy based on them, design an&#xD;
      organizational and methodological model for prevention of the cardiovascular complications,&#xD;
      and create an automated decision-making system for therapy selection to reduce the incidence&#xD;
      of cardiovascular events and related adverse outcomes compared to the traditional approach.&#xD;
      This is an interventional, randomized controlled trial, open-label study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to determine highly specific personified predictors of response to the therapy&#xD;
      by different groups of hypoglycemic drugs in patients with type 2 diabetes mellitus, to&#xD;
      develop on their basis a mathematical model that allows to objectify the choice of therapy&#xD;
      for each patient, and validate it in clinical practice with assessment of dynamic of&#xD;
      cardiovascular risk markers (vascular wall condition, markers of fibrosis and inflammation,&#xD;
      molecular-genetic markers of vascular damage, dynamic of intestinal microbiota, clinical&#xD;
      outcomes, psychological parameters of quality of life, eating, treatment satisfaction) and&#xD;
      pharmaco-economic component. Patients with type 2 diabetes mellitus and non-target HbA1c will&#xD;
      be randomized to receive antidiabetic drugs (SGLT-2 inhibitors, DPP-4 inhibitors, GLP-1&#xD;
      receptor agonists, sulfonylureas) in open prospective study according to: 1) standard&#xD;
      recommendations; 2) predictors chosen with automated decision-making system developed on the&#xD;
      literature analysis. At baseline and 3, 6, 12, and 24 months into the study patients will be&#xD;
      asked to complete the questionnaires on eating behavior, appetite, propensity to alcohol&#xD;
      consumption, smoking, level of physical activity, general health condition, level of anxiety&#xD;
      and depression, cognitive functions, adherence to treatment and treatment satisfaction. At&#xD;
      baseline and 3, 6, 12, and 24 months into the study there will be physical examination and&#xD;
      laboratory tests, including: fasting and 1.5 hours post meal glucose, glycated hemoglobin,&#xD;
      insulin with calculation of HOMA-IR index, indicators of lipid metabolism (total cholesterol,&#xD;
      TG, LDL, calculation of HDL and VLDL), markers of kidney function (serum creatinine with GFR&#xD;
      calculation, urine albumin-to-creatinine ratio), biochemical parameters of therapy safety&#xD;
      (ALT, AST, bilirubin, uric acid, fibrinogen, alkaline phosphatase, amylase 5), levels of&#xD;
      orexigenic / anorexigenic hormones (GLP1, GIP, ghrelin, leptin, glucagon, adiponectin,&#xD;
      C-peptide). The study will also include the evaluation of endothelial dysfunction (using&#xD;
      EndoPAT 2000), state of the vascular wall (using the SphygmoCor), thickness of intima-media&#xD;
      complex of carotid arteries, echocardiographic study, estimation of the global longitudinal&#xD;
      strain (2-D Speckle-tracking echocardiographic analysis), MRI of the heart, biomarkers of&#xD;
      inflammation (CRP level by the ultrasensitive method, adhesion molecules E-selectin and&#xD;
      sICAM-1), markers of oxidative stress (myeloperoxidase, paraoxanase-1), markers of fibrosis&#xD;
      (PICP, PIIINP, CITP, MMP / TIMP, TGF-β, galectin-3), markers of heart failure (NT-proBNP,&#xD;
      sST2). The investigators will conduct immunophenotyping of circulating progenitor cells (CD45&#xD;
      + / CD34 + / collagen-I +) by flow cytometry, and assess molecular-genetic markers of&#xD;
      endothelial damage (microRNA-126, microRNA-21, microRNA-27, miRNA-125 and miRoRNA-155).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>baseline and 3, 12, and 24 months after intervention</time_frame>
    <description>Change from baseline in HbA1c level (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body mass index</measure>
    <time_frame>baseline and 3, 12, and 24 months after intervention</time_frame>
    <description>Change from baseline in body mass index (kg/m^2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimated glomerular filtration rate</measure>
    <time_frame>baseline, 12 and 24 months after intervention</time_frame>
    <description>Change from baseline in level of estimated glomerular filtration rate (ml/min/1.73 m^2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HOMA-IR index</measure>
    <time_frame>baseline, 6 and 12 months after intervention</time_frame>
    <description>Change from baseline in level of HOMA-IR index (Homeostasis Model Assessment of Insulin Resistance) derived from the plasma insulin level (mIU/L) and plasma glucose level (mmol/L) of a participant: [(plasma insulin level) x (plasma glucose level)]/22.5, where the value of HOMA-IR index &gt; 2.0 suggests insulin resistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary creatinine-adjusted excretion of albumin</measure>
    <time_frame>baseline, 12 and 24 months after intervention</time_frame>
    <description>Change from baseline in level of urinary creatinine-adjusted excretion of albumin in morning spot urine samples (mg/mmol)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular parameters of PAT and IMT</measure>
    <time_frame>baseline, 6 and 12 months after intervention</time_frame>
    <description>Change from baseline in peripheral arterial tone by using EndoPAT 2000, the thickness of intima-media complex of carotid arteries (μm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL cholesterol</measure>
    <time_frame>baseline, 6 and 12 months after intervention</time_frame>
    <description>Change from baseline in level of LDL cholesterol (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>baseline, 6 and 12 months after intervention</time_frame>
    <description>Change from baseline in level of triglycerides (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NT-proBNP</measure>
    <time_frame>baseline, 6 and 12 months after intervention</time_frame>
    <description>Change from baseline in serum level of NT-proBNP (pmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hsCRP</measure>
    <time_frame>baseline, 6 and 12 months after intervention</time_frame>
    <description>Change from baseline in serum level of hsCRP ( mg/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PAT</measure>
    <time_frame>baseline, 6 and 12 months after intervention</time_frame>
    <description>Change from baseline in peripheral arterial tone by using EndoPAT 2000 (Ratio is created using the post and pre occlusion values)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IMT</measure>
    <time_frame>baseline, 6 and 12 months after intervention</time_frame>
    <description>Change from baseline in the thickness of intima-media complex of carotid arteries (μm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LV ejection fraction</measure>
    <time_frame>baseline, 6 and 12 months after intervention</time_frame>
    <description>Change from baseline in ejection fraction (%) by echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LV mass index</measure>
    <time_frame>baseline, 6 and 12 months after intervention</time_frame>
    <description>Change from baseline in LV mass index (g/m^2) by echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GLS by 2D-STE</measure>
    <time_frame>baseline, 6 and 12 months after intervention</time_frame>
    <description>Change from baseline in global longitudinal strain by 2D Speckle-tracking echocardiography (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Molecular-genetic markers of endothelial damage</measure>
    <time_frame>baseline, 6 and 12 months after intervention</time_frame>
    <description>Change from baseline in serum level of microRNA-126, microRNA-21, microRNA-27, miRNA-125 and miRoRNA-155 (relative units)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Treatment chosen by automated decision-making system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A: type 2 diabetic patients randomized to receive antidiabetic drugs according to predictors chosen with developed automated decision-making system: subgroup 1A- addition of vildagliptin 100 mg/day, subgroup 2A - addition of sitagliptin 100 mg/day, subgroup 3A- addition of dapagliflozin 10 mg/day, subgroup 4A- addition of empagliflozin 10 mg/day, subgroup 5A- addition of liraglutide 1,2-1,8 mg/day, subgroup 6A- addition of exenatide 20 μg/day, subgroup 7A - addition of glimepiride, subgroup 8A - addition of gliclazide.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment based on standard recommendations</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B: type 2 diabetic patients randomized to receive antidiabetic drugs according to standard recommendations : subgroup 1B- addition of vildagliptin 100 mg/day, subgroup 2B - addition of sitagliptin 100 mg/day, subgroup 3B- addition of dapagliflozin 10 mg/day, subgroup 4B- addition of empagliflozin 10 mg/day, subgroup 5B- addition of liraglutide 1,2-1,8 mg/day, subgroup 6B- addition of exenatide 20 μg/day, subgroup 7B - addition of glimepiride, subgroup 8B - addition of gliclazide.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Automatic system guided treatment</intervention_name>
    <description>Addition of: 1A -vildagliptin 100 mg/day 2A - sitagliptin 100 mg/day, 3A- dapagliflozin 10 mg/day 4A- empagliflozin 10 mg/day 5A- liraglutide 1,2-1,8 mg/day 6A- exenatide 20 μg/day 7A - glimepiride 8A - gliclazide</description>
    <arm_group_label>Treatment based on standard recommendations</arm_group_label>
    <arm_group_label>Treatment chosen by automated decision-making system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard treatment</intervention_name>
    <description>Addition of:&#xD;
B -vildagliptin 100 mg/day&#xD;
B - sitagliptin 100 mg/day,&#xD;
B- dapagliflozin 10 mg/day&#xD;
B- empagliflozin 10 mg/day&#xD;
B- liraglutide 1,2-1,8 mg/day&#xD;
B- exenatide 20 μg/day&#xD;
B - glimepiride&#xD;
B - gliclazide</description>
    <arm_group_label>Treatment based on standard recommendations</arm_group_label>
    <arm_group_label>Treatment chosen by automated decision-making system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female aged 17-70 years&#xD;
&#xD;
          2. Type 2 diabetes mellitus with non-target HbA1c exciding less than 1% (&lt;1%)&#xD;
&#xD;
          3. Initiation of the treatment by SGLT- 2 inhibitors, dipeptidyl peptidase-4 inhibitors,&#xD;
             GLP-1 analogues&#xD;
&#xD;
          4. Stable hypoglycemic therapy for 12 weeks before enrollment&#xD;
&#xD;
          5. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Type 1 diabetes mellitus&#xD;
&#xD;
          2. Recent acute coronary syndrome or acute disturbance of cerebral blood circulation&#xD;
             (less than 2 months ago)&#xD;
&#xD;
          3. Decompensation of chronic heart failure, chronic heart failure class IV (NYHA), acute&#xD;
             heart failure&#xD;
&#xD;
          4. Confirmed non-diabetic kidney disease (glomerulonephritis, pyelonephritis,&#xD;
             amyloidosis)&#xD;
&#xD;
          5. Chronic kidney disease requiring hemodialysis and/or urinary albumin concentration&#xD;
             (morning spot) &gt;1000 mg/L&#xD;
&#xD;
          6. Regular nephrotoxic drugs intake (long-term intake of NSAIDs, aminoglycosides,&#xD;
             sulfonamides, cyclosporine, lithium preparations)&#xD;
&#xD;
          7. Anamnesis of malignancy.&#xD;
&#xD;
          8. Diabetic foot ulcer and neuropathic osteoarthropathy&#xD;
&#xD;
          9. Anamnesis of bariatric surgery or surgical interventions on the gastrointestinal tract&#xD;
             leading to malabsorption.&#xD;
&#xD;
         10. Treatment with drugs reducing body weight less than 3 months ago or any other drugs&#xD;
             use that can lead to a change in body weight.&#xD;
&#xD;
         11. Liver disorders with elevation of ALT/AST exceeding three-fold the upper limit of&#xD;
             normal&#xD;
&#xD;
         12. Immunosuppressive therapy or regular nonsteroidal anti-inflammatory drugs intake&#xD;
&#xD;
         13. Change in the dosage of thyroid hormones less than 6 weeks ago.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Alina Babenko, MD, PhD</last_name>
    <phone>0078127025586</phone>
    <email>alina_babenko@mail.ru</email>
  </overall_contact>
  <location>
    <facility>
      <name>Alina Babenko</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197143</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alina Babenko</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>June 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>February 7, 2020</last_update_submitted>
  <last_update_submitted_qc>February 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health</investigator_affiliation>
    <investigator_full_name>Conrady Alexandra</investigator_full_name>
    <investigator_title>Deputy General Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03804411
org study id: 11/2017
nct id: NCT03804411
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a randomized controlled trial aimed to determine highly specific personified
      predictors of response to the therapy by different groups of hypoglycemic drugs (SGLT-2
      inhibitors, DPP-4 inhibitors, GLP-1 receptor agonists, sulfonylureas) in patients with type 2
      diabetes mellitus, develop an algorithm of personalized therapy based on them, design an
      organizational and methodological model for prevention of the cardiovascular complications,
      and create an automated decision-making system for therapy selection to reduce the incidence
      of cardiovascular events and related adverse outcomes compared to the traditional approach.
      This is an interventional, randomized controlled trial, open-label study.
The study aims to determine highly specific personified predictors of response to the therapy
      by different groups of hypoglycemic drugs in patients with type 2 diabetes mellitus, to
      develop on their basis a mathematical model that allows to objectify the choice of therapy
      for each patient, and validate it in clinical practice with assessment of dynamic of
      cardiovascular risk markers (vascular wall condition, markers of fibrosis and inflammation,
      molecular-genetic markers of vascular damage, dynamic of intestinal microbiota, clinical
      outcomes, psychological parameters of quality of life, eating, treatment satisfaction) and
      pharmaco-economic component. Patients with type 2 diabetes mellitus and non-target HbA1c will
      be randomized to receive antidiabetic drugs (SGLT-2 inhibitors, DPP-4 inhibitors, GLP-1
      receptor agonists, sulfonylureas) in open prospective study according to: 1) standard
      recommendations; 2) predictors chosen with automated decision-making system developed on the
      literature analysis. At baseline and 3, 6, 12, and 24 months into the study patients will be
      asked to complete the questionnaires on eating behavior, appetite, propensity to alcohol
      consumption, smoking, level of physical activity, general health condition, level of anxiety
      and depression, cognitive functions, adherence to treatment and treatment satisfaction. At
      baseline and 3, 6, 12, and 24 months into the study there will be physical examination and
      laboratory tests, including: fasting and 1.5 hours post meal glucose, glycated hemoglobin,
      insulin with calculation of HOMA-IR index, indicators of lipid metabolism (total cholesterol,
      TG, LDL, calculation of HDL and VLDL), markers of kidney function (serum creatinine with GFR
      calculation, urine albumin-to-creatinine ratio), biochemical parameters of therapy safety
      (ALT, AST, bilirubin, uric acid, fibrinogen, alkaline phosphatase, amylase 5), levels of
      orexigenic / anorexigenic hormones (GLP1, GIP, ghrelin, leptin, glucagon, adiponectin,
      C-peptide). The study will also include the evaluation of endothelial dysfunction (using
      EndoPAT 2000), state of the vascular wall (using the SphygmoCor), thickness of intima-media
      complex of carotid arteries, echocardiographic study, estimation of the global longitudinal
      strain (2-D Speckle-tracking echocardiographic analysis), MRI of the heart, biomarkers of
      inflammation (CRP level by the ultrasensitive method, adhesion molecules E-selectin and
      sICAM-1), markers of oxidative stress (myeloperoxidase, paraoxanase-1), markers of fibrosis
      (PICP, PIIINP, CITP, MMP / TIMP, TGF-β, galectin-3), markers of heart failure (NT-proBNP,
      sST2). The investigators will conduct immunophenotyping of circulating progenitor cells (CD45
      + / CD34 + / collagen-I +) by flow cytometry, and assess molecular-genetic markers of
      endothelial damage (microRNA-126, microRNA-21, microRNA-27, miRNA-125 and miRoRNA-155).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: HbA1c
time frame: baseline and 3, 12, and 24 months after intervention
description: Change from baseline in HbA1c level (%)
measure: Body mass index
time frame: baseline and 3, 12, and 24 months after intervention
description: Change from baseline in body mass index (kg/m^2)
measure: Estimated glomerular filtration rate
time frame: baseline, 12 and 24 months after intervention
description: Change from baseline in level of estimated glomerular filtration rate (ml/min/1.73 m^2)
measure: HOMA-IR index
time frame: baseline, 6 and 12 months after intervention
description: Change from baseline in level of HOMA-IR index (Homeostasis Model Assessment of Insulin Resistance) derived from the plasma insulin level (mIU/L) and plasma glucose level (mmol/L) of a participant: [(plasma insulin level) x (plasma glucose level)]/22.5, where the value of HOMA-IR index > 2.0 suggests insulin resistance
measure: Urinary creatinine-adjusted excretion of albumin
time frame: baseline, 12 and 24 months after intervention
description: Change from baseline in level of urinary creatinine-adjusted excretion of albumin in morning spot urine samples (mg/mmol)
measure: Cardiovascular parameters of PAT and IMT
time frame: baseline, 6 and 12 months after intervention
description: Change from baseline in peripheral arterial tone by using EndoPAT 2000, the thickness of intima-media complex of carotid arteries (μm)
measure: LDL cholesterol
time frame: baseline, 6 and 12 months after intervention
description: Change from baseline in level of LDL cholesterol (mmol/L)
measure: Triglycerides
time frame: baseline, 6 and 12 months after intervention
description: Change from baseline in level of triglycerides (mmol/L)
measure: NT-proBNP
time frame: baseline, 6 and 12 months after intervention
description: Change from baseline in serum level of NT-proBNP (pmol/L)
measure: hsCRP
time frame: baseline, 6 and 12 months after intervention
description: Change from baseline in serum level of hsCRP ( mg/L)
measure: PAT
time frame: baseline, 6 and 12 months after intervention
description: Change from baseline in peripheral arterial tone by using EndoPAT 2000 (Ratio is created using the post and pre occlusion values)
measure: IMT
time frame: baseline, 6 and 12 months after intervention
description: Change from baseline in the thickness of intima-media complex of carotid arteries (μm)
measure: LV ejection fraction
time frame: baseline, 6 and 12 months after intervention
description: Change from baseline in ejection fraction (%) by echocardiography
measure: LV mass index
time frame: baseline, 6 and 12 months after intervention
description: Change from baseline in LV mass index (g/m^2) by echocardiography
measure: GLS by 2D-STE
time frame: baseline, 6 and 12 months after intervention
description: Change from baseline in global longitudinal strain by 2D Speckle-tracking echocardiography (%)
measure: Molecular-genetic markers of endothelial damage
time frame: baseline, 6 and 12 months after intervention
description: Change from baseline in serum level of microRNA-126, microRNA-21, microRNA-27, miRNA-125 and miRoRNA-155 (relative units)
arm group label: Treatment chosen by automated decision-making system
arm group type: Experimental
description: Group A: type 2 diabetic patients randomized to receive antidiabetic drugs according to predictors chosen with developed automated decision-making system: subgroup 1A- addition of vildagliptin 100 mg/day, subgroup 2A - addition of sitagliptin 100 mg/day, subgroup 3A- addition of dapagliflozin 10 mg/day, subgroup 4A- addition of empagliflozin 10 mg/day, subgroup 5A- addition of liraglutide 1,2-1,8 mg/day, subgroup 6A- addition of exenatide 20 μg/day, subgroup 7A - addition of glimepiride, subgroup 8A - addition of gliclazide.
arm group label: Treatment based on standard recommendations
arm group type: Experimental
description: Group B: type 2 diabetic patients randomized to receive antidiabetic drugs according to standard recommendations : subgroup 1B- addition of vildagliptin 100 mg/day, subgroup 2B - addition of sitagliptin 100 mg/day, subgroup 3B- addition of dapagliflozin 10 mg/day, subgroup 4B- addition of empagliflozin 10 mg/day, subgroup 5B- addition of liraglutide 1,2-1,8 mg/day, subgroup 6B- addition of exenatide 20 μg/day, subgroup 7B - addition of glimepiride, subgroup 8B - addition of gliclazide.
intervention type: Drug
intervention name: Automatic system guided treatment
description: Addition of: 1A -vildagliptin 100 mg/day 2A - sitagliptin 100 mg/day, 3A- dapagliflozin 10 mg/day 4A- empagliflozin 10 mg/day 5A- liraglutide 1,2-1,8 mg/day 6A- exenatide 20 μg/day 7A - glimepiride 8A - gliclazide
arm group label: Treatment based on standard recommendations
arm group label: Treatment chosen by automated decision-making system
intervention type: Drug
intervention name: Standard treatment
description: Addition of:
B -vildagliptin 100 mg/day
B - sitagliptin 100 mg/day,
B- dapagliflozin 10 mg/day
B- empagliflozin 10 mg/day
B- liraglutide 1,2-1,8 mg/day
B- exenatide 20 μg/day
B - glimepiride
B - gliclazide
arm group label: Treatment based on standard recommendations
arm group label: Treatment chosen by automated decision-making system
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Alina Babenko, MD, PhD
phone: 0078127025586
email: alina_babenko@mail.ru
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
investigator full name: Conrady Alexandra
investigator title: Deputy General Director
mesh term: Diabetes Mellitus, Type 2