Randomized Crossover study to compare the effects of trelagliptin and omarigliptin on type 2 diabetes mellitus patients who were formerly treated with other DPP-4 inhibitors

Randomized Crossover study to compare the effects of trelagliptin and omarigliptin on type 2 diabetes mellitus patients who were formerly treated with other DPP-4 inhibitors - Randomized Crossover study to compare the effects of trelagliptin and omarigliptin on type 2 diabetes mellitus patients who were formerly treated with other DPP-4 inhibitors

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029743

Enrollment

100

Registered

2017-10-29

Start date

2016-01-04

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 melltus

Interventions

In the first period(for four months from the start), the former DPP-4 inhibitor is changed to trelagliptin 100mg, in the second period( for four months from the fifth month) trelagliptin is changed to

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes patients who have been treated with once or twice daily DPP-4 inhibitors for more than three months.

Exclusion criteria

Exclusion criteria: Type 1 diabetic patients. Patients with a history of severe ketosis or diabetic coma in previous 6 months. Patients with severe infection, before/after surgery or severe traumatic injury. Patients to have a plan to be pregnant. Patients with severe gastroenteric disturbance as exemplified by severe gastro-paresis. Patients with a history of pancreatitis

Design outcomes

Primary

Measure	Time frame
Change in HbA1c between the start and the fourth month and that between the fourth and the eighth month	—

Secondary

Measure	Time frame
Change in 1.5-AG, Urinary albumin (mg/gCr), and urinary protein (g/gCr) between the start and the fourth month and that between the fourth and the eighth month. Number of patients who choose either medicine on the eighth month. Change in HbA1c between the eighth and the 12th month.	—

Countries

Japan

Contacts

Public ContactTatsuya Haga

Haga Diabetes Clinic Internal Medicine

haga@fuga.ocn.ne.jp0567-28-7700

Outcome results

None listed

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