NCT03804411

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2017

Longer than P75 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

2.6 years

First QC Date

June 8, 2018

Last Update Submit

February 7, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • HbA1c

    Change from baseline in HbA1c level (%)

    baseline and 3, 12, and 24 months after intervention

  • Body mass index

    Change from baseline in body mass index (kg/m\^2)

    baseline and 3, 12, and 24 months after intervention

Secondary Outcomes (14)

  • Estimated glomerular filtration rate

    baseline, 12 and 24 months after intervention

  • HOMA-IR index

    baseline, 6 and 12 months after intervention

  • Urinary creatinine-adjusted excretion of albumin

    baseline, 12 and 24 months after intervention

  • Cardiovascular parameters of PAT and IMT

    baseline, 6 and 12 months after intervention

  • LDL cholesterol

    baseline, 6 and 12 months after intervention

  • +9 more secondary outcomes

Study Arms (2)

Treatment chosen by automated decision-making system

EXPERIMENTAL

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.

Drug: Automatic system guided treatmentDrug: Standard treatment

Treatment based on standard recommendations

EXPERIMENTAL

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.

Drug: Automatic system guided treatmentDrug: Standard treatment

Interventions

Automatic system guided treatmentDRUG

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

Treatment based on standard recommendationsTreatment chosen by automated decision-making system
Standard treatmentDRUG

Addition of: 1. B -vildagliptin 100 mg/day 2. B - sitagliptin 100 mg/day, 3. B- dapagliflozin 10 mg/day 4. B- empagliflozin 10 mg/day 5. B- liraglutide 1,2-1,8 mg/day 6. B- exenatide 20 μg/day 7. B - glimepiride 8. B - gliclazide

Treatment based on standard recommendationsTreatment chosen by automated decision-making system

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female aged 17-70 years
  • Type 2 diabetes mellitus with non-target HbA1c exciding less than 1% (\<1%)
  • Initiation of the treatment by SGLT- 2 inhibitors, dipeptidyl peptidase-4 inhibitors, GLP-1 analogues
  • Stable hypoglycemic therapy for 12 weeks before enrollment
  • Signed informed consent

You may not qualify if:

  • Type 1 diabetes mellitus
  • Recent acute coronary syndrome or acute disturbance of cerebral blood circulation (less than 2 months ago)
  • Decompensation of chronic heart failure, chronic heart failure class IV (NYHA), acute heart failure
  • Confirmed non-diabetic kidney disease (glomerulonephritis, pyelonephritis, amyloidosis)
  • Chronic kidney disease requiring hemodialysis and/or urinary albumin concentration (morning spot) \>1000 mg/L
  • Regular nephrotoxic drugs intake (long-term intake of NSAIDs, aminoglycosides, sulfonamides, cyclosporine, lithium preparations)
  • Anamnesis of malignancy.
  • Diabetic foot ulcer and neuropathic osteoarthropathy
  • Anamnesis of bariatric surgery or surgical interventions on the gastrointestinal tract leading to malabsorption.
  • Treatment with drugs reducing body weight less than 3 months ago or any other drugs use that can lead to a change in body weight.
  • Liver disorders with elevation of ALT/AST exceeding three-fold the upper limit of normal
  • Immunosuppressive therapy or regular nonsteroidal anti-inflammatory drugs intake
  • Change in the dosage of thyroid hormones less than 6 weeks ago.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alina Babenko

Saint Petersburg, 197143, Russia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Alina Babenko, MD, PhD

CONTACT

0078127025586alina_babenko@mail.ru

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy General Director

Study Record Dates

First Submitted

June 8, 2018

First Posted

January 15, 2019

Study Start

August 1, 2017

Primary Completion

March 1, 2020

Study Completion

May 1, 2020

Last Updated

February 10, 2020

Record last verified: 2020-02

Locations

RU(1)