Status:
UNKNOWN
Prognostic Predictors of Response to Hypoglycemic Therapy
Lead Sponsor:
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 inhibitor...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT03804411
Start Date
August 1 2017
End Date
May 1 2020
Last Update
February 10 2020
Active Locations (1)
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1
Alina Babenko
Saint Petersburg, Russia, 197143