UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014249 |
|---|---|
| Receipt number | R000016598 |
| Scientific Title | Efficacy and safety of combination therapy with GLP-1 analog lixisenatide and long-acting insulin glargine in patients with glucose intolerance or diabetes caused by hyposecretion of endogenous insulin who underwent partial pancreatectomy |
| Date of disclosure of the study information | 2014/06/12 |
| Last modified on | 2015/06/05 15:39:51 |
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Basic information
Public title
Efficacy and safety of combination therapy with GLP-1 analog lixisenatide and long-acting insulin glargine in patients with glucose intolerance or diabetes caused by hyposecretion of endogenous insulin who underwent partial pancreatectomy
Acronym
Efficacy and safety of combination therapy with GLP-1 analog lixisenatide and long-acting insulin glargine in patients with diabetes who underwent partial pancreatectomy
Scientific Title
Efficacy and safety of combination therapy with GLP-1 analog lixisenatide and long-acting insulin glargine in patients with glucose intolerance or diabetes caused by hyposecretion of endogenous insulin who underwent partial pancreatectomy
Scientific Title:Acronym
Efficacy and safety of combination therapy with GLP-1 analog lixisenatide and long-acting insulin glargine in patients with diabetes who underwent partial pancreatectomy
Region
| Japan |
Condition
Condition
patients with glucose intolerance or diabetes caused by hyposecretion of endogenous insulin who underwent partial pancreatectomy
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of combination therapy with GLP-1 analog lixisenatide in patients with diabetes who underwent partial pancreatectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c, FPG, 1- and 2-hour PPG, CPR
Key secondary outcomes
Frequency of hypoglycemia , change in body weight , frepuency of Gastrointestinal disorders, visceral fat and subcutaneous fat
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
From admission, pretreatment drugs were discontinued , adjust the insulin glargine dose to keep FPG100-130mg/dl. After achievement of aim FPG, start lixisenatide in addition to insulin glargine. Patient take in hospitalization foods fixed for only breakfast ,measure glucose before breakfast, 1- and 2-hour PPG , before lunch by SMBG. Duration of lixisenatide treatment is 12 weeks
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with glucose intolerance or diabetes caused by hyposecretion of endogenous insulin who underwent partial pancreatectomy
Key exclusion criteria
Patient for whom insulin treatment is necessary (type 1 diabetes, total pancreatectomy)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Kitazawa |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Division of Diabetes, Endocrinology and Metabolism, Department of Medicine
Zip code
Address
3-18-22 Bunkyo-ku, Tokyo Honkomagome
TEL
03-3823-2101
cickkitazawa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Kitazawa |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
3-18-22 Bunkyo-ku, Tokyo Honkomagome
TEL
03-3823-2101
Homepage URL
cickkitazawa@gmail.com
Sponsor or person
Institute
Division of Diabetes, Endocrinology and Metabolism, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 12 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 12 | Day |
Last modified on
| 2015 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016598
