Comparison of efficacy and safety of exenatide extended-release and dulaglutide in type 2 diabetes mellitus patients who are insufficiently controlled with oral antidiabetic agents

Comparison of efficacy and safety of exenatide extended-release and dulaglutide in type 2 diabetes mellitus patients who are insufficiently controlled with oral antidiabetic agents - Comparison of efficacy and safety of exenatide extended-release and dulaglutide in type 2 diabetes mellitus patients who are insufficiently controlled with oral antidiabetic agents

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019096

Enrollment

Registered

2015-09-24

Start date

2015-09-24

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 mellitus

Interventions

From the start to the end of the study patients are treated with exenatide extended-release every week. From the start to the end of the study patients are treated with dulaglutide every week.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: HbA1c is higher than or equal to 6.5% or BMI is higher than or equal to 25. Patients are not planned to be treated with prohibited combined drugs.

Exclusion criteria

Exclusion criteria: Type 1 diabetes mellitus patients. Patients with a history of severe ketosis or diabetic coma in previous 6 months. Patients with severe infection, before/after surgery or with 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 of HbA1c,body weight at the 52th and the 104th week. As for patients with renal disturbance, change of serum creatinine, urine albumin(mg/gCr), urine protein (g/gCr) at the 52th and the 104th week. As for patients over 70 years old, change of MMSE at the 52th and the 104th week.	—

Secondary

Measure	Time frame
Change of data shown below at the 52th and the 104th week. AST, ALT, gamma-GTP, LDL-C, HDL-C,TG, non-HOL-C, serum creatinine, serum UA, eGFR, 1,5-AG, self-monitoring blood glucose, Urine albumin(mg/gCr),Urine protein (g/gCr)	—

Countries

Japan

Contacts

Public ContactTatsuya Haga

Haga Diabetes Clinic Internal Medicine

tatsuya-umin@hagadm.com0567-28-7700

Outcome results

None listed

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