Insulin combined with the DPP-4 inhibitor sitagliptin for diabetes: evaluation study

Insulin combined with the DPP-4 inhibitor sitagliptin for diabetes: evaluation study - I-UNITE Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011346

Enrollment

10000

Registered

2013-08-01

Start date

2013-07-01

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

Type2 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Type 2 diabetes patients 2 Over twenty years of age 3 Receiving sitagliptin add-on therapy with insulin therapy under usual care 4 Continuing constant diabetes treatment before the sitagliptin add-on therapy more than three months.

Exclusion criteria

Exclusion criteria: 1 Hypersensitivity to sitagliptin 2 Patients who had severe ketosis or diabetic coma within 6 months 3 Severe infection or trauma, perioperative 4 Patients whose participation is deemed inappropriate at the discretion of the attending physician

Design outcomes

Primary

Measure	Time frame
1 Efficacy (1)HbA1c and blood glucose at 0, 3, 6 months and 1, 2 years after starting sitagliptin add-on therapy (2)Information of insulin therapy 2 Safety Hypoglycemia and other adverse events and those rates of occurrence	—

Countries

Japan

Contacts

Public ContactNobuyuki Shihara

Japan Association for Diabetes Education and Care secretariat

shihara@nittokyo.or.jp03-3514-1721

Outcome results