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Efficacy and safety observation of recombination Benaglutide and sitagliptin vs. Benaglutide monotherapy in type 2 diabetic patients with unsatisfied glycemia control under metformin treatment

Efficacy and safety observation of recombination Benaglutide and sitagliptin vs. Benaglutide monotherapy in type 2 diabetic patients with unsatisfied glycemia control under metformin treatment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017126
Enrollment
Unknown
Registered
2018-07-13
Start date
2018-07-23
Completion date
Unknown
Last updated
2018-07-16

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

Conditions

Type 2 Diabetes

Interventions

Bena:Benaglutide
Bena_Sita:Benaglutide and sitagliptin

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Participants signed informed consent; 2. Aged from 18 to 70 (include); 3. Diagnosed type 2 diabetes (criteria of WHO, 1999); 4. Body mass index is above 21 and no more than 40.0 kg/m2; 5. HbA1c is above 8% and no more than 11%; 6. Before the scranning, participant was treated with metformin in a dose more than 1000mg per day and for more than 3 months; 7. Judged by investigator, participant can and is eager to obey: 8. According to investigation, insist to treatment during the whole study; 9. Participate the interview and follow-up by telephone; 10. Avoid to pregnant.

Exclusion criteria

Exclusion criteria: 1) Allergic to benaglutide, sitagliptin, or any component or contraindications or intolerance 2) Use of drug weight loss before screening 3) The subject experienced more than 3 severe hypoglycemias within 6 months prior to screening. 4) Use insulin and insulin sensitizer within 3 months before screening 5) abnormal liver function, alanine aminotransferase (ALT) is greater than the upper limit of 2 times 6) Chronic kidney injury, creatinine (Cr) >133µmol/L 7) Patients with severe heart disease, such as heart failure, unstable angina, myocardial infarction 8) Patients with vestibular diseases 9) Patients with malignant tumors and active tuberculosis 10) Those taking glucocorticoids (excluding topical or inhaled medications)

Design outcomes

Primary

MeasureTime frame
HbA1c;blood glucose;

Countries

China

Contacts

Public ContactYanyan Chen

Fuwai Hospital, Chinese Academy of Medical Sciences

doc.yan@medmail.com.cn+86 010-88396585

Outcome results

None listed

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