Skip to content

Evaluation of efficacy and safety of combination therapy of Henggligin, Retagliptin and Metformin in new type 2 diabetes patients

Evaluation of efficacy and safety of combination therapy of Henggligin, Retagliptin and Metformin in new type 2 diabetes patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093342
Enrollment
Unknown
Registered
2024-12-03
Start date
2024-12-07
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

type 2 Diabetes (T2DM)

Interventions

Control group:Metformine
Test group:Hengglizin 10 mg qd + Repagliptin 100 mg qd + metformin 500mg bid

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Untreated patients with primary T2DM; 2. Age >=18 years old; 3. 8.0%= 60 ml/min1.73m^2; 6. Voluntarily participate and sign informed consent;

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women and women of childbearing age who do not want to use reliable contraception; 2. People who are known to be allergic to hengglagliptin, repagliptin or metformin; 3. Other types of diabetes except type 2 diabetes; 4. Type 2 diabetes mellitus with a history of ketoacidosis (DKA) within the last 6 months; 5. NYHA heart grade IV; 6. Hospital admission for acute coronary syndrome (ST elevation myocardial infarction, non-ST elevation myocardial infarction, or unstable angina pectoris), percutaneous coronary intervention, or cardiac surgery within 30 days before the screening visit; Or plan to undergo percutaneous coronary intervention or heart surgery within 3 months. 7. Confirmed respiratory diseases (such as chronic obstructive pulmonary disease, pulmonary hypertension, etc.); 8. Previous acute or chronic pancreatitis; 9. Uncontrolled hypertension, defined as systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg during the screening visit (the average of three blood pressure measurements in the supine position); 10. Patients with postural hypotension and/or systolic blood pressure <90 mmHg at visit 0 or visit 1, or who are considered hypovolemic by the clinician; 11. For patients with diagnosed malignant tumors, life expectancy is less than 1 year; 12. Patients with a history of repeated urinary and reproductive tract infections (clinician judgment); 13. Patients participating in other clinical trials within 3 months; 14. Addiction to alcohol or drugs. 15. In addition to the above, the investigators judged that the patients were not suitable to participate in this clinical trial;

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
weight;waistline;Seven point blood sugar;FBG(fasting blood-glucose);Fasting plasma C-peptide /FCP;fasting insulin FINS;2-hour C-peptide;2-hour insulin;liver function;renal function;blood lipid;UACR;blood routine examination;urinalysis;

Countries

China

Contacts

Public ContactJunqing Zhang

Peking University First Hospital

junqing.zhang@pkufh.com+86 10 83575662

Outcome results

None listed

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