Efficacy and safety of switching from TWIce-daily exenatide to oNce-weekly exenatide in Japanese patients with type 2 diabetes mellitus;Multicenter, Prospective, Single-arm trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016390

Enrollment

Registered

2015-02-01

Start date

2015-02-01

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

Adult patients with type 2 diabetes mellitus (over 20 years of age)

Interventions

In patients who are dosed with exenatide at 10 to 20 microgram/day 2 times/day (BID) for 12 weeks or longer, this dose method is to be switched to 2 mg/time once a week (QW), followed by continuous ad

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Adult patients with type 2 diabetes mellitus (over 20 years of age) (2) Patients treated with Byetta (over 12 weeks) (combined use of sulphonylurea, biguanide and/or thiazolidinedione is permissible) (3) Patients from whom written informed consent for participation is obtained.

Exclusion criteria

Exclusion criteria: (1) Patients with type 1 diabetes mellitus, (2) Patients with diabetic ketoacidosis (3) Patients with diabetic coma and pre-coma (4) Patients with history of serious hypersensitivity to exenatide or any of its components (5) Patients who are pregnant or who intend to become pregnant (6) Patients with severe infections (7) Patients at emergency surgery (8) Patients with severe renal dysfunction, and patients on dialysis (9) Any other condition which the attending physician feels would interfere with trial participation

Design outcomes

Primary

Measure	Time frame
Change in HbA1c level at week 24	—

Secondary

Measure	Time frame
Change in the following measurements at week 24 ?Glucose, GA, and 1,5-AG ?Percentage of patients achieving less than 7 % of HbA1c ?7-point Self Monitoring of Blood Glucose (SMBG) ?Height, body weight ?Waist Circumference ?Blood pressure, pulse ?Beta-cell function, insulin resistance Insulin C-peptide HOMA-Beta, HOMA-IR Proinsulin/Insulin Ratio Glucagon ?Biochemical markers: Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Serum creatinine Uric acid Total cholesterol HDL-cholesterol Triglyceride (TG) Free Fatty Acid (FFA) Amylase, Lipase ?Oxidative stress, inflammatory markers High-sensitivity CRP (hsCRP) Adiponectin 8-hydroxy-2'-deoxyguanosine (8-OHdG) 8-iso-prosraglandin F2alfa(8-isoPFG2alfa) ?The Japanese Version of Questionnaire about gastrointestinal symptom ?The Japanese Version of the Diabetes Treatment Satisfaction Questionnaire (DTSQs) ?Diabetes-Medication Satisfaction Tool (DM-SAT) ?Questionnaire for hypoglycaemia ?Adverse events Event name Expression day Seriousness Severity Outcome Outcome confirmation day Causation ?Optional measurements: Change in the following measurements at week 24. Blood glucose levels and glycemic variability obtained by continuous glucose monitoring (CGM) Incidence of hypoglycaemic episodes detected by CGM Endothelial function by flow-mediated dilatation (FMD) Visceral fat measured by computed tomography (CT) imaging Gastrointestinal motility function (13C breath test)	—

Measure

Time frame

Change in the following measurements at week 24 ?Glucose, GA, and 1,5-AG ?Percentage of patients achieving less than 7 % of HbA1c ?7-point Self Monitoring of Blood Glucose (SMBG) ?Height, body weight ?Waist Circumference ?Blood pressure, pulse ?Beta-cell function, insulin resistance Insulin C-peptide HOMA-Beta, HOMA-IR Proinsulin/Insulin Ratio Glucagon ?Biochemical markers: Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Serum creatinine Uric acid Total cholesterol HDL-cholesterol Triglyceride (TG) Free Fatty Acid (FFA) Amylase, Lipase ?Oxidative stress, inflammatory markers High-sensitivity CRP (hsCRP) Adiponectin 8-hydroxy-2'-deoxyguanosine (8-OHdG) 8-iso-prosraglandin F2alfa(8-isoPFG2alfa) ?The Japanese Version of Questionnaire about gastrointestinal symptom ?The Japanese Version of the Diabetes Treatment Satisfaction Questionnaire (DTSQs) ?Diabetes-Medication Satisfaction Tool (DM-SAT) ?Questionnaire for hypoglycaemia ?Adverse events Event name Expression day Seriousness Severity Outcome Outcome confirmation day Causation ?Optional measurements: Change in the following measurements at week 24. Blood glucose levels and glycemic variability obtained by continuous glucose monitoring (CGM) Incidence of hypoglycaemic episodes detected by CGM Endothelial function by flow-mediated dilatation (FMD) Visceral fat measured by computed tomography (CT) imaging Gastrointestinal motility function (13C breath test)

—

Countries

Japan

Outcome results

None listed

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