UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016959 |
|---|---|
| Receipt number | 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 10:27:29 |
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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
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
y-kiyohara@osakah.johas.go.jp
Sponsor or person
Institute
Osaka Rosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019602
