Value of Glycated Albumin in Intervention of Glycemic Control in Chinese Patients With Type 2 Diabetes

Launched by ASAHI KASEI PHARMA CORPORATION · Jan 27, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether using a specific blood test called Glycated Albumin (GA) can help doctors better manage blood sugar levels in newly diagnosed patients with Type 2 Diabetes. Currently, another test called HbA1c is commonly used, but it may not be sensitive enough for some patients who need their diabetes medication adjusted. The study will involve 200 participants from 10 hospitals in China. They will be divided into two groups: one group will have their diabetes treatment adjusted based on their GA levels, while the other group will follow standard treatment guidelines without knowing their GA levels. Researchers will then compare how well both groups achieve their blood sugar goals after 12 weeks.

To be eligible for this trial, participants should be between 20 and 70 years old, have been recently diagnosed with Type 2 Diabetes (or have had it for less than a year without medication for three months), and have a specific range of HbA1c levels. However, individuals with certain serious health conditions, recent surgeries, or other specific medical issues will not be able to join. If you participate, you can expect close monitoring of your blood sugar levels and treatment adjustments tailored to your individual needs, contributing to a better understanding of diabetes management.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.