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A comparative study of insulin combined with SGLT2 inhibitors/metformin in newly diagnosed type 2 diabetes patients

A comparative study of insulin combined with SGLT2 inhibitors/metformin in newly diagnosed type 2 diabetes patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116249
Enrollment
Unknown
Registered
2026-01-07
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

diabetes

Interventions

The group receiving only insulin:Only using insulin-based medications (such as rapid-acting, premixed, long-acting insulins, etc.) for blood sugar control, without combining other types of hypoglycemi
The group treated with metformin and insulin:The combination of metformin and insulin-based drugs is used for hypoglycemic treatment, without additional use of other types of hypoglycemic drugs (such
The group treated with empagliflozin10mg + Insulin:The treatment for lowering blood sugar was carried out using 10mg of empagliflozin in combination with insulin drugs, without additional use of other

Sponsors

Tianjin Medical University Chu Hsien-I Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. At least 18 years old; 2. Meets the diagnostic criteria for type 2 diabetes as stipulated in the 2020 CDS guidelines, with the diagnosis made within less than 3 months; 3. Initiates insulin treatment for the first time; 4. At the time of diagnosis, fasting blood glucose is greater than 10 mmol/L, and HbA1c is greater than 9.0% 5. Voluntarily participates in and cooperates with the study and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combined with severe acute complications such as ketoacidosis; 2. Incompatible conditions for the use of SGLT inhibitors and metformin; 3.Patients with severe liver and kidney damage; 4. Pregnant or expecting pregnant patients; 5. Patients who are unwilling to participate in this trial.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
Self-Monitoring of Blood Glucose, SMBG;Insulin Dose;Grade 2 and Grade 3 Hypoglycemia Incidence and Rate;Grade 2 and Grade 3 Nocturnal Hypoglycemia Incidence and Rate; Body Weight;Lipid Profile;Uric Acid;Urine Albumin-to-Creatinine Ratio;Renal Oxygenation Level;Number of Patients with Diabetes Reversal;

Countries

China

Contacts

Public ContactLi Jing

Tianjin Medical University Chu Hsien-I Memorial Hospital

2003-victor@163.com+86 133 7039 3157

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026