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A comparative study of acarbose, vildagliptin and saxagliptin intended for better efficacy and safety on type 2 diabetes mellitus treatment

A comparative study of acarbose, vildagliptin and saxagliptin intended for better efficacy and safety on type 2 diabetes mellitus treatment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040826
Enrollment
Unknown
Registered
2020-12-11
Start date
2016-01-01
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 mellitus

Interventions

Acarbose group:Acarbose tablets orally (100 mg/tablet, Bayer, Leverkusen, Germany) 3 times each day with 100 mg each time
Vildagliptin group:vildagliptin tablets orally (50 mg/tablet, AstraZeneca, Cambridge, London, England) 2 times each day with 50 mg each time
Saxagliptin group:saxagliptin tablets orally (5 mg/tablet, AstraZeneca, Cambridge, London, England) one time each day with 5 mg each time

Sponsors

Affiliated Hospital of Qiingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with type 2 diabetes were diagnosed by the 1999 WHO diagnostic criteria; 2. course of disease was within 12months, not used hypoglycemic drugs, or medication history < 1 months, but the group did not use drugs for the first 3 months; 3. No gender perference; 4. the enrolled patients aged 18 - 75 years; 5. HbA1C level was 7.0%-11.0% in the first follow-up visit; 6. FBG levelwas 7.5mmol/L-13.0mmol/L in the first follow-up visit; 7. ALT and AST were within the normal range in the first and third time time follow-up; 8. Patients voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. In this test before March in the use of insulin, a-glucosidase inhibitor, thiazolidine ketone, Gregory two resistant, DDPIV inhibitors or other biguanides hypoglycemic drugs in patients; 2. Patients with diabetic ketoacidosis; 3. ECG showed left ventricular hypertrophy (LVH), which showed the maximum voltage of the S wave of the V1 lead and the maximum voltage of the R wave or R wave of the V6 lead and > 3.5mV of the maximum voltage of V5; 4. Patients with severe cardiovascular diseases including myocardial infarction, coronary artery angioplasty or bypass graft, unstable angina, heart failure; or patients with serious cardiovascular system disease; 5. In the first follow-up, antihypertensive drugs were still unable to control blood pressure (>110mmHg). Patients with simple systolic hypertension who had a systolic blood pressure of first > 180mmHg during follow-up; 6. Patients who had a history of cerebrovascular accident within 6 months before the trial; 7. Had a history of chemotherapy and radiotherapy for liver cirrhosis and malignant tumor, or patients with active hepatitis or who had a history of active hepatitis within 6 months before the trial; 8. Suffering from severe nephropathy (such as plasma creatinine > 1.8mg/dl or > 160 mol/L); 9. People with persistent microscopic hematuria or unexplained gross hematuria; 10. Any infection caused by kidney disease or arterial insufficiency, including open foot ulcers; 11. men with anemia of Hb 400ml; 17. patients with a history of chronic alcoholism or a history of drug abuse within 5 years prior to the start of the trial; 18. in the first 6 months before the start of the trial had been abdominal, chest or vascular surgery; 19. with gastrointestinal tract (Crohn's disease, ulcerative colitis) disease and surgical history; 20. patients with a history of long-term use or misuse of the history of; 21. in this experiment, the need to frequently used or may require antibiotics or regulation of gastrointestinal flora of drug use or need to frequently used or may require the use of any of the listed in section 5.4.2 of the ban on the use of drugs; 22. patients who are unwilling or unable to comply with this plan or schedule.

Design outcomes

Primary

MeasureTime frame
Flora change;HBA1C;fasting blood-glucose;

Countries

China

Contacts

Public ContactWang Yan'gang

Affiliated Hospital of Qiingdao University

wangyg1965@yahoo.com+86 18661807293

Outcome results

None listed

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