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Clinical study of duluning in the treatment of type 2 diabetes mellitus

Randomized, open, parallel controlled, multicenter clinical trial comparing duluning and gehuazhi in the treatment of type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040939
Enrollment
Unknown
Registered
2020-12-16
Start date
2017-05-24
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

Type 2 diabetes

Interventions

control group:gehuazhi

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. According to the 1999 who diagnostic criteria for type 2 diabetes mellitus; 2. Patients with type 2 diabetes who have not been treated with any hypoglycemic drugs since the first clinical diagnosis or previous diagnosis; 3. Doctors think it is necessary to take metformin treatment; 3) 7.5% <= HbA1c <= 11.0% 4) BMI 19 <= BMI <= 42; 5) The age was 18-75 years (including the end value), and the gender was not limited; 6) Be able to understand the procedure and method of this study, and be willing to complete the trial in strict accordance with the clinical trial protocol and sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: (1) Patients with other diseases need to take other drugs that affect glucose metabolism; (2) Pregnant or lactating women or those preparing for pregnancy recently; (3) After treatment with antihypertensive drugs, the systolic blood pressure was more than or equal to 160 mmHg and or DBP >= 100 mmHg; (4) In the first 6 months of randomization, patients with negligently compensated heart failure (NYHA grade III and IV), unstable angina pectoris, stroke or transient ischemic attack, myocardial infarction, persistent and clinical significance arrhythmia, coronary artery bypass grafting or percutaneous coronary intervention operation; (5) Before randomization, severe chronic gastrointestinal disease or previous treatment that may affect drug absorption methods, such as gastrointestinal surgery; (6) Abnormal liver and kidney function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) were positive the normal upper limit is 3 times, and the serum creatinine (CR) is higher than the upper limit of normal value. (7) Have mental or nervous system disease, unwilling to communicate or language barrier, unable to fully understand and cooperate; (8) It is expected that people with poor compliance: such as patients living and working environment is not stable in non local resident population; (9) Drinking more than 50g a day; (10) Participants in other clinical trials within 3 months before randomization; (11) the researchers believe that patients have any other factors that may affect the evaluation of this study.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
HbA1c<=7.0%;Changes of fasting blood glucose;Change of utility value before and after treatment;GLP-1 changes;

Countries

China

Contacts

Public ContactGuo Lixin

Beijing Hospital

glx1218@163.com+86 13901317569

Outcome results

None listed

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