TYPE 2 DIABETES
Conditions
Interventions
Experimental group:calcium dobesilate
Control group:placebo
Sponsors
Tongji Hospital, Tongji Medical College of HUST
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male and/or female patients with type 2 diabetes mellitus according to Chinese Diabetes Society definition; 2. Aged >=18 years; 3. HbA1c 30-1000 mg/g at visit 2; 5. GFR >30 ml/min at visit 2 (only 20% of population (n=24) with an eGFR of 30-59.9 ml/min); 6. Patients on stable treatment to control hypertension, hyperglycemia and (if applicable) dyslipidemia for one month prior to visit 2; 7. Stable treatment with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARBs) for one month prior to visit 2; 8. Willing and able to understand and sign an approved Informed Consent form.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus; 2. Recent cardiovascular events (3 months); 3. Uncontrolled hypertension on visit 2 or 3 (average of 3 measurements above 160 mmHg systolic or 100 mmHg diastolic) 4. Dialysis and/or acute kidney injury within 3 months before screening; 5. Significant edema, infectious diseases, leg ulcers; 6. Severe concurrent disease with a life expectancy of less than a year or which, in the judgment of the investigator, would interfere significantly with the assessments of safety and efficacy during this study; 7. Patient with known active infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C; 8. Regular daily use of immune suppressants, steroid therapy (except for topical use or inhalation), non-steroidal anti-inflammatory drug (NSAIDs) or two or more diuretic drugs at visit 2; 9. Dual blockade with an angiotensin receptor blocker and an angiotensin converting enzyme inhibitor within the one month prior to visit 2; 10. Treatment with aliskiren or spironolactone within the one month prior to visit 2; 11. Treatment with calcium dobesilate within one month prior to visit 2; 12. In the judgment of the clinical investigator, patients who are likely to be non-compliant or uncooperative during the study; 13. Previous participation (randomization) in this study; 14. More than threefold elevated liver enzymes (AST or ALT); 15. Clinical diagnosis of non-diabetic kidney disease; 16. Hematuria ++ or greater at visit 2; 17. Subjects who have a history of nephrotic syndrome; 18. Subjects who have had a kidney transplant; 19. Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin). A subject is considered cured if there has been no evidence of cancer recurrence in the previous 5 years; 20. Subjects who are investigational staff members or relatives of those site staff members; 21. Treatment with any other investigational agent, or participation in another clinical study within 30 days prior to baseline visit and at least 4 half-lives after intake of the last study medication; 22. Pregnant females; breastfeeding females; 23. Female patients not using an appropriate contraceptive method.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR; | — |
Secondary
| Measure | Time frame |
|---|---|
| eGFR;HbA1c; | — |
Countries
China
Contacts
Public ContactGang Yuan
Tongji Hospital, Tongji Medical College of HUST
Outcome results
None listed