Blood-Glucose reduction in Type 2 Diabetes Patients when using two different DPP-4, alogliptin or sitagliptin during 52-week administration

Blood-Glucose reduction in Type 2 Diabetes Patients when using two different DPP-4, alogliptin or sitagliptin during 52-week administration - Blood-Glucose reduction using DPP-4 agents

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007487

Enrollment

300

Registered

2012-03-20

Start date

2011-10-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Type 2 diabetes

Interventions

alogliptin 25mg, tablet, daily, oral Duration 52 weeks sitagliptin 50mg,tablet, daily, oral Duration 52 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes patients having Hba1c with more than 6.5% and under 9.0% for 3 months or more using oral anti-DM drug(s) except for selective DPP-4 inhibitors under diet and/or exercise therapy 1. Gender both, 20 years old or more 2. be able to understood fullly, and comply regarding the study protocol 3. Written informed consent taken prior to the enrollment 4. Outpatients

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes or secondary diabetes 2. Patients with severe infecious disease, operation planned or just after done, and/or serious externalinjyury 3. Other DPP-4 agents users on the enrollement 4. Insulin users 5. Pregnant and possible pregnant, or Lactation 6. AST or ALT 2.5 times or more of normalvalue 7. Serum creatinine2 mg/dL or more 8. Patients with old myocardial infarction, angina pectoris and/or stroke 9. Patients having history of hypersensitivity against study drugs 10.Inappropriate reasons on the enrollment that the physicians/investigators are judged

Design outcomes

Primary

Measure	Time frame
Reduction value of HbA1c level (JDS) at 12, 24, 36, 52 (terminal) if comparing with at 0 (enrolled)	—

Secondary

Measure	Time frame
Fasting blood glucose Patient rate completed	—

Countries

Japan

Contacts

Public ContactHiroko Usami

Biomedis International Ltd Study Management

hiroko-u@biomedis.co.jp81-1-3-3575-1611

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026