UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Elucidation of Mechanisms Underlying Prolonged Glucose-lowering Effect of Exenatide LAR in Japanese T2DM Patients
Title of the study (Brief title)	Effect of Exenatide LAR on Gastric Emptying in Japanese T2DM Patients
Region	Japan

Condition
Condition	T2DM
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the effect of exenatide LAR on gastric emptying, a major determinant of postprandial glycemia, using C13-acetate breath test
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Tlag (Tmax-cal) and T1/2 on C13-acetate breath test carried out after insulin/exenatide LAR treatment
Key secondary outcomes

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Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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 mg/dl. Exenatide LAR therapy is subsequently initiated at 2 mg QW.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Japanese T2DM patients (2)Patients treated with OAD and/or injection therapy including insulin and GLP-1 receptor agonist except exenatide LAR (3)HbA1c >= 7.0% at screening visit (4)Male and female patients aged 20-80 years
Key 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
Target sample size	20

Research contact person
Name of lead principal investigator	Makoto Ohashi
Organization	Osaka Rosai Hospital
Division name	Center for Diabetes Mellitus
Address	1179-3 Nagasone-cho, Sakai, Osaka 591-8025, Japan
TEL	072-252-3561
Email	otokam@osakah.johas.go.jp

Public contact
Name of contact person	Yoshimoto Kiyohara
Organization	Osaka Rosai Hospital
Division name	Center for Diabetes Mellitus
Address	1179-3 Nagasone-cho, Sakai, Osaka 591-8025, Japan
TEL	072-252-3561
Homepage URL
Email	y-kiyohara@osakah.johas.go.jp

Sponsor
Institute	Osaka Rosai Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪労災病院 / Osaka Rosai Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 02 Month 29 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 24 Day
Last modified on	2016 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024877