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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016959
Receipt No. R000019602
Scientific Title Effect of Lixisenatide on Gastric Emptying in Japanese T2DM Patients Analysed by C13 Breath Test
Date of disclosure of the study information 2015/04/01
Last modified on 2016/04/29

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Basic information
Public title Effect of Lixisenatide on Gastric Emptying in Japanese T2DM Patients Analysed by C13 Breath Test
Acronym Effect of Lixisenatide on Gastric Emptying in Japanese T2DM Patients
Scientific Title Effect of Lixisenatide on Gastric Emptying in Japanese T2DM Patients Analysed by C13 Breath Test
Scientific Title:Acronym Effect of Lixisenatide 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 lixisenatide 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/lixisenatide treatment
Key secondary outcomes

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 a target fasting plasma glucose level of less than 140 mg/dl. Lixisenatide therapy is subsequently initiated at 10 microgram QD, and the dose is increased in increments of 5 microgram at 1- or 2-day intervals to a maximum level of 20 microgram QD.
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

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 lixisenatide
(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
1st name
Middle name
Last name Makoto Ohashi
Organization Osaka Rosai Hospital
Division name Center for Diabetes Mellitus
Zip code
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
1st name
Middle name
Last name Yoshimoto Kiyohara
Organization Osaka Rosai Hospital
Division name Center for Diabetes Mellitus
Zip code
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

Funding Source
Organization Japan Labour Health and Welfare Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2015 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 29 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=R000019602

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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