Elucidation of Mechanisms Underlying Glucose-lowering Effect of Dulaglutide Using C13-acetate Breath Test and Its Anti-arteriosclerotic Effect Using Endothelial Function Test in Japanese Working T2DM Patients

Elucidation of Mechanisms Underlying Glucose-lowering Effect of Dulaglutide Using C13-acetate Breath Test and Its Anti-arteriosclerotic Effect Using Endothelial Function Test in Japanese Working T2DM Patients - Effect of Dulaglutide on Gastric Emptying in Japanese T2DM Patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026679

Enrollment

Registered

2017-04-01

Start date

2017-04-01

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

T2DM

Interventions

Antidiabetic treatment carried out before admission is switched to insulin therapy on admission. The dose of insulin is titrated up to achieve the target fasting plasma glucose level of less than 140

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Japanese working T2DM patients (2)Patients treated with OAD and/or injection therapy including insulin and GLP-1 receptor agonist except dulaglutide (3)HbA1c >= 7.0% at screening visit (4)Male and female patients aged 20-70 years

Exclusion criteria

Exclusion criteria: (1)Patients with history of chronic pancreatitis, inflammatory bowel disease, pancreatectomy or gastrectomy (2)Patients with history of metabolic acidosis including diabetic ketoacidosis during the previous 1 year (3)Patients with history of stroke or myocardial infarction requiring hospitalization during the previous 6 months (4)Patients with severe or uncontrolled congestive heart failure (5)Patients with drug or alcohol abuse during the previous 6 months (6)Patients having hepatic dysfunction with AST or ALT greater than 5 times the upper limit of the normal laboratory range at the time of screening (7)Patients having uncontrolled hypertension with a resting systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mmHg at the time of screening (8)Patients with end-stage renal dysfunction and/or dialysis (9)Patients having clinically relevant history of gastrointestinal disease with prolonged nausea and vomiting during the previous 6 months (10)Pregnant or possibly pregnant women (11)Patients judged as inadequate to participate in the present study by Investingator or sub-investigator

Design outcomes

Primary

Measure	Time frame
Tlag (Tmax-cal) and T1/2 on C13-acetate breath test carried out after insulin/dulaglutide treatment	—

Countries

Japan

Contacts

Public ContactYoshimoto Kiyohara

Osaka Rosai Hospital Center for Diabetes Mellitus

y-kiyohara@osakah.johas.go.jp072-252-3561

Outcome results

None listed

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