Status:
COMPLETED
Value of Glycated Albumin in Intervention of Glycemic Control in Chinese Patients With Type 2 Diabetes
Lead Sponsor:
Asahi Kasei Pharma Corporation
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
HbA1c is widely used as the gold standard for evaluating glycemic control. However, in patients who need adjusting hypoglycemic regimen, A1c was not a sensitive marker. In comparison, serum GA level c...
Detailed Description
At present, glycosylated hemoglobin (HbA1c) is widely used as the gold standard for evaluating glycemic control. However, as a marker of average blood glucose level, HbA1c has some limitations. HbA1c ...
Eligibility Criteria
Inclusion
- 20-70 years of age
- newly diagnosed T2DM or duration of T2DM less than 1 year and without anti-diabetic medications for 3 months prior to screening
- HbA1c ≥7.5% and \<10.5%
Exclusion
- Requiring treatment of proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot, diabetic ketoacidosis, or hyperglycemic hyperosmolar status in recent 3 months prior to screening.
- The following history or conditions in recent 6 months prior to screening: (i) decompensated cardiac insufficiency (NYHA class III or IV); (ii)myocardial infarction, coronary artery bypass grafting or coronary stent implantation; (iii) uncontrolled severe arrhythmia and is not suitable to participate in this study evaluated by the investigator; (iv) hemorrhagic stroke or ischemic stroke and is not suitable to participate in this study evaluated by the investigator.
- Laboratory indicators meet one of the following criteria: (i) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3× upper limit of normal(ULN); (ii) total bilirubin \> 2× ULN; (iii) hemoglobin \<100g/L; (iv)total protein \<60g/L; (v)albumin \<30g/L; (vi) glomerular filtration rate(eGFR)\<60 ml min-1 per 1.73 m2.
- Thalassemia, hemolytic anemia and other diseases that may cause erythrocyte instability and affect the measurement of HbA1c.
- Uncontrolled thyroid dysfunction.
- Systemic corticosteroids treatment in recent 1 month prior to screening (exception of inhalation or local external treatment).
- Pregnancy or lactating.
- Two or more episodes of severe hypoglycemia in recent 1 year prior to screening.
- Patient who need to initiate treatment with sulfonylureas, glinides, insulin or insulin analogues evaluated by the investigators.
- Patient is being treated with calcium dobesilate or has a disease requiring calcium dobesilate treatment, or may be treated with calcium dobesilate in the near future evaluated by the investigators.
- Patients considered unsuitable for observation by investigators.
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05227677
Start Date
August 15 2022
End Date
December 31 2024
Last Update
December 4 2025
Active Locations (7)
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1
The third people's hospital of DATONG
Datong, Shanxi, China
2
Beijing Haidian Hospital
Beijing, China
3
Beijing Pinggu District Hospital
Beijing, China
4
Beijing Shijingshan Hospital
Beijing, China