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Efficacy Comparison of Sitagliptin and Acarbose on Drug-Naive 0atients with Type 2 Diabetes: A Prospective, Open-Label, Randomized Clinical Trial

Efficacy Comparison of Sitagliptin and Acarbose on Drug-Naive 0atients with Type 2 Diabetes: A Prospective, Open-Label, Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002271
Enrollment
Unknown
Registered
2012-06-14
Start date
2010-04-15
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Diabetes

Interventions

Group A:sitagliptin monotherapy
Group B:Acarbose monotherapy

Sponsors

Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Sign the written informed consent before the study; 2. Aged 18 to 75; 3. Patients with type 2 diabetes (ADA criteria, 2010); 4. BMI between 19kg/m2 to 43/kg/m2; 5. HbA1c 6.5% to 10.0%; 6. Without use of any kind of anti-diabetic drugs in 8 weeks.

Exclusion criteria

Exclusion criteria: 1. Without sufficient ability to communicate and to fulfill the study; 2. Type 1 diabetes or other special kinds of diabetes; 3. Severe infection, cancer, stressful situation includes trauma, surgery; 4. Patients with any other kinds of endocrine diseases,with any autoimmune disease or connective tissue disease; 5. Patients in gestation period, lactation period or want to have prengancy in study period; 6. Random blood glucose level >=14.4mmol/L in inclusion period; 7. Allergic to active pharmaceutical ingredients; 8. Abnormal liver function (Transaminase higher than 2.5 times the upper limit of normal) and abnormal renal function(blood Scr >50µmol/L) ; 9)Severe systemic disease ; 10)Acute ,chronic pancreatitis or pancreatectomy history; 11)Use of any kind of drugs which can affect study, includes corticosteroid,immunosuppressive agents; 12) Patients with mental disorder; addictive to any kinds of drug ,Smokers or alcohol abuser; 13)Participates in other trials within 3 months; 14)Patients that researchers regard not eligible for inclusion.;

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
Blood glucose;Ghrelin;Insulin;Glucago;

Countries

China

Contacts

Public ContactYaoming Xue
yaomingxue@126.com+86 020 61641631

Outcome results

None listed

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