Investigation of efficacy and safety of add-on therapy with DPP-4 inhibitor in type 2 diabetic patients poorly controlled with basal supported oral therapy

Investigation of efficacy and safety of add-on therapy with DPP-4 inhibitor in type 2 diabetic patients poorly controlled with basal supported oral therapy - Study of add-on therapy with DPP-4 inhibitor in diabetic patients uncontrolled with BOT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010849

Enrollment

Registered

2013-05-31

Start date

2013-06-01

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

patients who take the addition of DPP-4 inhibitor patients who do not take the addition of DPP-4 inhibitor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Type 2 diabetic patients with HbA1c(NGSP) 7.0% and more despite the target of fasting glucose level <110mg/dl by titrating insulin 2)Age: 20 to 79 years 3)No concern about the gender 4)Written informed consent are taken for the enrollment

Exclusion criteria

Exclusion criteria: 1)Patients with a history of hypersensitivity to vildagliptin 2)Patients with diabetic ketoacidosis, diabetic coma and type 1 diabetes 3)Patients with severe liver dysfunction 4)Patients with severe infection, perioperative and severe trauma 5)Patients with moderate renal dysfunction or endstage renal disease on hemodialysis 6)Patients with heart failure (NYHA/New York Heart Association stage 3 or severer) 7)Pituitary insufficiency or adrenal insufficiency 8)Patienst with diarrhea, vomiting, starvation and irregular food intake 9)Patients with proliferative diabetic retinopathy 10)Patients who are pregnant, lactating, and possibly pregnant women and those planning to become pregnant

Design outcomes

Primary

Measure	Time frame
Change of HbA1c from baseline	—

Secondary

Measure	Time frame
Glucose daily profile by SMBG Frequency and severity of hypoglycemia Frequency of other adverse events	—

Countries

Japan

Outcome results

None listed

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