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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004645
Receipt No. 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

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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
Email

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
Email tsuguka@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Department of Endocrinology and Diabetes mellitus
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005139

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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