Prognostic Predictors of Response to Hypoglycemic Therapy

• Status: Recruiting
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Treatments: Empagliflozin; Exenatide; Gliclazide; Glimepiride; Hypoglycemic Agents; Liraglutide; Sitagliptin Phosphate; Vildagliptin

Criteria

Inclusion Criteria:

1. Male and female aged 17-70 years

2. Type 2 diabetes mellitus with non-target HbA1c exciding less than 1% (<1%)

3. Initiation of the treatment by SGLT- 2 inhibitors, dipeptidyl peptidase-4 inhibitors, GLP-1 analogues

4. Stable hypoglycemic therapy for 12 weeks before enrollment

5. Signed informed consent

Exclusion Criteria:

1. Type 1 diabetes mellitus

2. Recent acute coronary syndrome or acute disturbance of cerebral blood circulation (less than 2 months ago)

3. Decompensation of chronic heart failure, chronic heart failure class IV (NYHA), acute heart failure

4. Confirmed non-diabetic kidney disease (glomerulonephritis, pyelonephritis, amyloidosis)

5. Chronic kidney disease requiring hemodialysis and/or urinary albumin concentration (morning spot) >1000 mg/L

6. Regular nephrotoxic drugs intake (long-term intake of NSAIDs, aminoglycosides, sulfonamides, cyclosporine, lithium preparations)

7. Anamnesis of malignancy.

8. Diabetic foot ulcer and neuropathic osteoarthropathy

9. Anamnesis of bariatric surgery or surgical interventions on the gastrointestinal tract leading to malabsorption.

10. 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.

11. Liver disorders with elevation of ALT/AST exceeding three-fold the upper limit of normal

12. Immunosuppressive therapy or regular nonsteroidal anti-inflammatory drugs intake

13. Change in the dosage of thyroid hormones less than 6 weeks ago.