UMIN-CTR Clinical Trial

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