Twin-exenatide Study

JRCT ID: jRCTs031180320

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Adult patients with type 2 diabetes mellitus
• Date of first enrollment: 04/03/2015
• Target sample size: 59
• Study type: Interventional
• Intervention(s): 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 administration for further 24 weeks.

Outcome(s)

• Primary Outcome: Change in HbA1c level at week 24

Secondary Outcome

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-prostaglandin 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
Onset 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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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 intend to become pregnant, and patients who are pregnant, parturient or lactating
(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

Related Information

• Primary Sponsor: Itoh Hiroshi
• Secondary Sponsor: Nonprofit Organization Hokkaido Health-Science Institute
• Secondary ID(s): UMIN000016390