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

NCT05227677 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-04

Study results available
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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.

Conditions

Interventions

OTHER

current guidelines to adjust treatment

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.

OTHER

GA guided anti-diabetic therapy adjustment

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.

Sponsors & Collaborators

  • Asahi Kasei Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Linong Ji, Professor · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2024-08-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05227677 on ClinicalTrials.gov