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Evaluation of the Effectiveness and Strategy Optimization of a New Individualized Diagnosis and Treatment Plan for Type 2 Diabetes Mellitus: A National Multicenter RCT Study - Evaluation of the Effectiveness of an Auxiliary Decision Support System Combined with the Long-Acting DPP-4 Enzyme Inhibitor Cofrogliptin in MARD Type

Evaluation of the Effectiveness and Strategy Optimization of a New Individualized Diagnosis and Treatment Plan for Type 2 Diabetes Mellitus: A National Multicenter RCT Study - Evaluation of the Effectiveness of an Auxiliary Decision Support System Combined with the Long-Acting DPP-4 Enzyme Inhibitor Cofrogliptin in MARD Type

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122927
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-04-25
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

Observation group:Received treatment with the long-acting DPP4 enzyme inhibitor, saxagliptin, at a dose of 10 mg every two weeks (Q2W).
Experimental group:The experimental group was treated with 10mg of saxagliptin every two weeks (Q2W) in combination with an auxiliary decision support system. This auxiliary decision support system is

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age over 60 years old; 2. Newly diagnosed with type 2 diabetes within the past year; 3.Only received DPP-4 inhibitor daily preparations and/or metformin treatment within the 3 months prior to enrollment; 4.FPG < 15 mmol/L and HbA1c <= 10.5% within the 3 months prior to enrollment. 5. Able to understand the procedures and methods of this trial, willing to comply with the clinical research protocol to complete this trial, and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Participants who had experienced acute diabetic events within 6 months before enrollment; 2.Those with severe diseases (such as cancer, HIV, severe peripheral vascular disease, various immune system diseases, severe mental disorders or language barriers); 3. Those who had used other drugs that might affect glucose metabolism within 6 months before enrollment (such as systemic glucocorticoids, growth hormones, etc.); 4. Those who had experienced acute coronary syndrome, stroke or transient ischemic attack within 3 months before enrollment, or had uncontrolled hypertension (such as systolic blood pressure = 160mmHg, diastolic blood pressure = 90mmHg) before enrollment; 5.Those who were participating in other clinical trials; 6. Other situations deemed unsuitable for participation in this study by the researchers.

Design outcomes

Primary

MeasureTime frame
Change of HbA1c from baseline;

Secondary

MeasureTime frame
Time in range (TIR);Diabetes treatment satisfaction questionnaire;Time above target glucose range (TAR);Time below target range (TBR);Mean glucose level (MG);Coefficient of variation (CV) of blood glucose;Serious Adverse events;Hypoglycemic events;

Countries

China

Contacts

Public ContactQi Pan

Beijing Hospital

panqi621@126.com+86 189 0133 0621

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026