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Comparison of the effects of two hypoglycemic regimens: GLP-1RAs monotherapy versus fixed-dose combination of GLP-1RAs and insulin, on clinical remission and metabolic indicators in newly diagnosed type 2 diabetic patients

Comparison of the effects of two hypoglycemic regimens: GLP-1RAs monotherapy versus fixed-dose combination of GLP-1RAs and insulin, on clinical remission and metabolic indicators in newly diagnosed type 2 diabetic patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128323
Enrollment
Unknown
Registered
2026-07-17
Start date
2025-03-14
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

type 2 diabetes

Interventions

FRC+Metformin group:Combination Preparations (FRC) plus Metformin Sustained-Release Tablets
GLP-1RAs+Metformin group:GLP-1RAs plus Metformin Sustained-Release Tablets
Metformin group + Placebo group:Metformin Extended-Release Tablets Placebo

Sponsors

Shanghai Pudong New Area People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18–75 years old; 2. FPG >= 11.1 mmol/L and/or HbA1c >= 9.0%; 3. BMI >= 24 kg/m^2; 4. Disease course: 0~12 months; 5. All three islet autoantibodies are negative; 6. No prior treatment with any hypoglycemic drugs.

Exclusion criteria

Exclusion criteria: 1. Patients with Type 1 diabetes mellitus and specific types of diabetes mellitus; 2. Patients complicated with acute complications of diabetes mellitus (DM), infection, severe hepatic and renal impairment, as well as cardiac insufficiency; 3. Patients with medullary thyroid carcinoma or multiple endocrine neoplasia type 2 combined with diabetes mellitus; 4. Patients with a history of pancreatitis; 5. Pregnant, lactating females or those with a pregnancy plan.

Design outcomes

Primary

MeasureTime frame
clinical remission of type 2 diabetes;Changes in pancreatic ß -cell function;

Secondary

MeasureTime frame
Changes in body weight;

Countries

China

Contacts

Public ContactTaoqin

Shanghai Pudong New Area People's Hospital

1595246828@qq.com+86 21 20509000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026