UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004645 |
|---|---|
| Receipt number | R000005139 |
| Scientific Title | A comparative study of Sitagliptin- Glimepiride combinational therapy and Glimepiride monotherapy on the patients with diabetes mellitus after pancreatic biliary diseases including malignant disorders related subtotal pancreatectomy |
| Date of disclosure of the study information | 2010/12/02 |
| Last modified on | 2019/07/09 12:50:06 |
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Basic information
Public title
A comparative study of Sitagliptin- Glimepiride combinational therapy and Glimepiride monotherapy on the patients with diabetes mellitus after pancreatic biliary diseases including malignant disorders related subtotal pancreatectomy
Acronym
A comparative study of Sitagliptin- Glimepiride combinational therapy and Glimepiride monotherapy on the patients with diabetes mellitus after subtotal pancreatectomy
Scientific Title
A comparative study of Sitagliptin- Glimepiride combinational therapy and Glimepiride monotherapy on the patients with diabetes mellitus after pancreatic biliary diseases including malignant disorders related subtotal pancreatectomy
Scientific Title:Acronym
A comparative study of Sitagliptin- Glimepiride combinational therapy and Glimepiride monotherapy on the patients with diabetes mellitus after subtotal pancreatectomy
Region
| Japan |
Condition
Condition
Diabetes mellitus after pancreatic biliary diseases including malignant disorders related subtotal pancreatectomy
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comparative study of Sitagliptin- Glimepiride combinational therapy and Glimepiride monotherapy on the patients with diabetes mellitus after subtotal pancreatectomy by pancreatic endocrine secretion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Delta C-peptide in glucagon injection.
(delta C-peptide = max C-peptide – base C-peptide)
Comparison the mean of delta C-peptide from before treatment to the end of the study between Sitagliptin- Glimepiride combinational therapy and Glimepiride monotherapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
50 mg of Sitagliptin monotherapy once daily on diabetes mellitus after subtotal pancreatectomy. If necessary, Glimepiride therapy will be combined
Interventions/Control_2
0.5 mg of Glimepiride monotherapy once daily on diabetes mellitus after subtotal pancreatectomy
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(a) Patients were underwent subtotal pancreatectomy.
(b) Patients are outpatients or inpatients
(c) Patients need anti-diabetic agents after subtotal pancreatectomy.
(d) Patients with a therapy of diabetes mellitus before subtotal pancreatectomy.
Key exclusion criteria
(a) Patients with a history of total pancreatectomy.
(b) Patients with insulin-dependent diabetes mellitus.
(c) Patients with a history of severe cardiovascular or cerebrovascular disease or renal failure.
(c) Patients have contraindication of Sitagliptin, Glimepiride and glucagon.
(d) Patients with severe liver damage.
(e) Patients are pregnant or patients breast-feeding, potentially pregnant.
(f) Patients who are diagnosed to be ineligible by the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuhei Nakanishi |
Organization
Hiroshima University Hospital
Division name
Department of Endocrinology and Diabetes mellitus
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL
082-257-5198
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuguka Shiwa |
Organization
Hiroshima University Hospital
Division name
Department of Endocrinology and Diabetes mellitus
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL
082-257-5198
Homepage URL
tsuguka@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Department of Endocrinology and Diabetes mellitus
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2010 | Year | 12 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2010 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 01 | Day |
Last modified on
| 2019 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005139
