An open label, randomized control study for the comparison of effectiveness between biguanides and Dipeptidyl peptidase-4 (DPP-4) inhibitor in people with type 2 diabetes

An open label, randomized control study for the comparison of effectiveness between biguanides and Dipeptidyl peptidase-4 (DPP-4) inhibitor in people with type 2 diabetes - An open label, randomized control study for the comparison of effectiveness between biguanides and Dipeptidyl peptidase-4 (DPP-4) inhibitor in people with type 2 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010385

Enrollment

Registered

2013-04-01

Start date

2013-04-07

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

biguanides Dipeptidyl peptidase-4 inhibitor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Type 2 diabetes 2)HbA1c >=6.5% during 8 weeks prior to the study 3)Treated with none or single oral hypoglycemic agent or insulin over 12 weeks prior to the study

Exclusion criteria

Exclusion criteria: 1.Hypersensitivity to or contraindication of biguanides and alogliptin 2.Type 1 diabetes, gestational diabetes mellitus, secondary diabetes 3.Medical history and/or complication of diabetic ketoacidosis 4.Medical history and/or complication of severe hypoglycemia 5.Severe infection, before and after surgery, patients with severe trauma 6.Patients treated with metformin or alogliptin within 4 weeks before the start of treatment 7.Patients introduced or those undergoing systemic administration of steroids 8.unstable glycemic control 9.Patients with severe renal impairment, including patients requiring hemodialysis or peritoneal dialysis (Less than more than more than Ccr 30mL / expression Cockcraft, man serum creatinine >2.5mg/dL, woman serum creatinine >2.0mg/dL) 10.Severe hypertension (systolic blood pressure > 100mmHg or diastolic blood pressure > 160mmHg) 11.The patients with severe heart disease of congestive heart failure, myocardial infarction, unstable angina within one year onset 12.Proliferative retinopathy or macular edema requiring treatment 13.History of malignancy or the treatment of malignancy within 1 year 14.Serious complications (Grade 3 classification as a guide to adverse drug reactions Ministry of Health, Labour and Welfare) 15.During pregnancy and lactation. 16.Other cases physicians sharing test was deemed inappropriate as the subject of the study or investigator.

Design outcomes

Primary

Measure	Time frame
The change of body composition WC, BW, the amount of fat,the amount of muscle mass, and so on	—

Countries

Japan

Contacts

Public ContactToshinari Takamura

Kanazawa University Graduate School of Medical Science Department of Disease Control and Homeostasis

ttakamura@m-kanazawa.jp076-265-2231

Outcome results

None listed

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