Skip to content

Randomized, open, positive, parallel-controlled multicenter clinical trial comparing the efficacy, safety, and cost-effectiveness of dulening and Metformin in the treatment of type 2 diabetes mellitus

Randomized, open, positive, parallel-controlled multicenter clinical trial comparing the efficacy, safety, and cost-effectiveness of dulening and Metformin in the treatment of type 2 diabetes mellitus

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041280
Enrollment
Unknown
Registered
2020-12-23
Start date
2017-05-26
Completion date
Unknown
Last updated
2021-03-08

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

Control group:Glucophage

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) The diagnostic criteria for type 2 diabetes in line with WHO in 1999. 2) Type 2 diabetes mellitus patients who have not been treated with any hypoglycemic drugs after initial or previous diagnosis are considered necessary by physicians. 3) 7.5% or less than HbA1c 11%. 4) body mass index (BMI) is 19 or less than 42. 5) the age is 18-75 years old (including the end value), and the sex is not limited. 6) Understand the procedures and methods of this study, be willing to complete the trial strictly in accordance with the clinical trial plan, and sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1) Other diseases need to take other drugs that affect glucose metabolism. 2) Pregnant or lactating women or those who are preparing for pregnancy in the near future. 3) Hypertension that is difficult to control. After antihypertensive treatment, systolic blood pressure (> 160 mmHg) and diastolic blood pressure (> 100 mmHg) were measured three times in succession. 4) Fault-compensated heart failure (NYHA classified as III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistent and clinically significant arrhythmia, coronary artery bypass grafting or percutaneous coronary intervention occurred within 6 months before randomization. 5) Severe chronic gastrointestinal disorders before randomization or having received treatment that may affect drug absorption, such as gastrointestinal surgery; 6) Liver and kidney dysfunction: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was 3 times the normal upper limit, and serum creatinine (Cr) was higher than the normal upper limit. 7) Those with mental or nervous system disorders who are unwilling to communicate or have language barriers and are unable to fully understand and cooperate with others; 8) Populations with poor compliance to the trial, such as non-resident populations with unstable living and working conditions; 9) Alcohol consumption was greater than 50g per day. 10) Patients who participated 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;

Countries

China

Contacts

Public ContactLixin Guo

Beijing Hospital

cptlcb@163.com+86 18087296259

Outcome results

None listed

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