Skip to content

The Clinical Efficacy and Safety Studies of Sanye Tablets Treatment of Type 2 Diabetes Mellitus and Hyperlipidemia

Clinical Studies of Components Compatibility of New Drugs - Sanye Glycolipids Tablet

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-15006702
Enrollment
Unknown
Registered
2015-07-01
Start date
2015-07-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Type 2 Diabetes Mellitus and Hyperlipidemia

Interventions

Trial group:Sanye Tablets + Acarbose Simulation Agent
The placebo group:Sanye Tablets Simulation Agent + Acarbose Simulation Agent
Positive medicine control group:Acarbose +Sanye Tablets Simulation Agent

Sponsors

Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with Type 2 Diabetes (FGB 7.0-10.0mmol/L, 7%=2.26 mmo1/L; 4. Aged 18 to 75 years old; 5. Before and after 2 weeks period of check: FGB, TG are less than 15%; 6. Voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Have Diabetes Ketosis, Ketoacidosis, Severe Infection and Trauma, Major Surgery nearly a month; 2. Accompanied by Liver and Kidney Dysfunction (AST, ALT>1.5 times normal cap, Serum Creatinine>upper limit of normal), Lung Dysfunction, Heart Failure, severe primary diseases such as Acute Myocardial Infarction; 3. With severe chronic diabetes complications (such as Diabetic Nephropathy, Diabetic Fundus Lesions); 4. Pregnancy, ready for pregnancy or lactation; 5. Our Chinese native medicine ingredient in drug allergy; 6. Psychiatric patients; 7. In other clinical trials of patients for nearly three months; 8. The use of Heparin, Thyroxine and other drugs affect blood lipid metabolism of patients.

Design outcomes

Primary

MeasureTime frame
HbAlc;

Secondary

MeasureTime frame
FBG;TC;TG;HDL-C;LDL-C;FINS;FGly;OGTT2hPG;EPC;CEC;OGTT2hGly;

Countries

China

Contacts

Public ContactHUANG Yuhong
hyh101@126.com+86 13012264994

Outcome results

None listed

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