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Multicenter, Randomized, Active-Controlled Trial on the Impact of Henggliezin on Body Composition and Glycemic Metabolism in Type 2 Diabetic Patients

Multicenter, Randomized, Active-Controlled Trial on the Impact of Henggliezin on Body Composition and Glycemic Metabolism in Type 2 Diabetic Patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114486
Enrollment
Unknown
Registered
2025-12-12
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Type 2 Diabetes Mellitus

Interventions

SGLT2i group:Henggliezin 10 mg/day orally
Control group:Reglidine 100 mg/day orally

Sponsors

Shanghai East Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meets the WHO or ADA diagnostic criteria for type 2 diabetes, with a disease duration of no more than 1 year; 2. BMI >= 24 kg/m^2; 3. Age range: 18-75 years; 4. Blood sugar is controlled solely through lifestyle measures, without the use of hypoglycemic drugs.

Exclusion criteria

Exclusion criteria: 1.Patients with severe hepatic or renal dysfunction; gastrointestinal disorders; or acute complications. 2.History of confirmed or suspected alcohol or drug abuse, or the presence of any other condition that, in the investigator’s judgment, would reduce the likelihood of enrollment or complicate protocol compliance. 3.Any other condition or disease that, in the opinion of the investigator, would make the subject unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Body fat composition;

Secondary

MeasureTime frame
TNF-a;HBA1c;Fasting C-peptide;Lipid Profile;free fatty acid;FPG;ß-hydroxybutyrate;BDH1;IL-6;Fasting insulin;CPT-1;

Countries

China

Contacts

Public ContactPeicheng Li

Shanghai East Hospital

lipeicheng2012@163.com+86 21 3880 4518

Outcome results

None listed

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