CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
GA guided anti-diabetic therapy adjustment +1 moreother
Likely dose
Not stated in record
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Search/NCT05227677
NCT05227677N/ACompleted

Value of Glycated Albumin in Intervention of Glycemic Control in Patients With Type 2 Diabetes: A Multicenter, Randomized Controlled Clinical Study

Asahi Kasei Therapeutics Corporation·interventional·Posted Feb 7, 2022·Updated Dec 4, 2025

In Brief

A clinical study evaluating GA guided anti-diabetic therapy adjustment and current guidelines to adjust treatment for Type 2 Diabetes Mellitus. Completed, enrolled 200 participants across 7 sites.

Detailed 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 can reflect the average blood glucose level in the last 2\~3 weeks of diabetes. Therefore, investigators undertake this study to determine whether knowledge of GA values and adjusting anti-diabetic regimens according to GA values will result in improved glycemic control in newly diagnosed type 2 diabetes mellitus (T2DM). This multicenter randomized controlled clinical study will be conducted in 10 hospitals in China. A total of 200 patients with newly diagnosed T2DM will be 1:1 randomly assigned to two groups: intervention group (GA) and control group (NC). In GA group, the anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks. In NC group, investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment. At 12-week of follow-up,investigators compare the achievement rate of HbA1c(\<7%) between the two groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 7, 2022
Enrollment StartAug 15, 2022
Primary CompletionAug 31, 2024
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.4 years ago

Interventions

GA guided anti-diabetic therapy adjustmentother

The GA values will be measured at 4-week intervals in both groups. The anti-diabetic treatment regimen will be strengthened when GA value is higher than 16% at 4 weeks.

current guidelines to adjust treatmentother

The GA values will be measured at 4-week intervals. Investigators will be not aware of the GA value and rely on the current guidelines to adjust treatment.