Efficacy and safety of DPP-4 inhibitor added to insulin for treatment of type 2 diabetes

Efficacy and safety of DPP-4 inhibitor added to insulin for treatment of type 2 diabetes - Efficacy and safety of DPP-4 inhibitor added to insulin for treatment of type 2 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004678

Enrollment

Registered

2011-01-01

Start date

2011-01-01

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

DPP-4 inhibitor with intensive insulin therapy intensive insulin therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Outpatient 2.Patients with intensive insulin therapy 3.HbA1c =>6.5%(JDS). 4.Patients with type 2 diabetes mellitus. 5.No change in therapy with oral antidiabetes agent at least 2 months 6.Age =>20 years 7.Informed consent obtained.

Exclusion criteria

Exclusion criteria: 1.Type 1 diabetes mellitus 2.Impaired renal function [serum-creatinine; =>1.5mg/dL(male), =>1.3mg/dL(female) or eGFR<30mL/min] 3.Severe liver dysfunction [AST, ALT=>3 fold above ULN] 4.Patients who are disqualified from the study by investigator for any reasons.

Design outcomes

Primary

Measure	Time frame
HbA1c level after 6 months of treatment (amount and rate of change)	—

Secondary

Measure	Time frame
Amount and rate of change of items and these AUC after test meal(serum glucose, CPR, intact proinsulin, glucagon, FFA, Active GLP-1, Total GIP, TG) Amount and rate of change after 6 months of treatment(abdominal girth, daily profile of serum glucose by SMBG, Patients QOL questionnaire, Bio-markers for oxidant stress (8-isoprostane, 8-OHdG)) Amount and rate of change after 1, 2, 3, 4, 5, 6 months of treatment(Blood pressure, Body weight, HbA1c, GA, 1,5-AG, CPR, amount and frequency of insulin treatment, rate of hypoglycemic episodes)	—

Measure

Time frame

Amount and rate of change of items and these AUC after test meal(serum glucose, CPR, intact proinsulin, glucagon, FFA, Active GLP-1, Total GIP, TG) Amount and rate of change after 6 months of treatment(abdominal girth, daily profile of serum glucose by SMBG, Patients QOL questionnaire, Bio-markers for oxidant stress (8-isoprostane, 8-OHdG)) Amount and rate of change after 1, 2, 3, 4, 5, 6 months of treatment(Blood pressure, Body weight, HbA1c, GA, 1,5-AG, CPR, amount and frequency of insulin treatment, rate of hypoglycemic episodes)

—

Countries

Japan

Contacts

Public ContactYoshifumi Saisho

Keio University , School of Mecidicine Department of Internal Medicine

saish@sc.itc.keio.ac.jp03-5363-3797

Outcome results

None listed

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