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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000017566
Receipt No. R000020337
Scientific Title Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2015/05/18
Last modified on 2015/05/14

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Basic information
Public title Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus
Acronym Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus
Scientific Title Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus
Scientific Title:Acronym Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of sitagliptin and glimepiride regarding clinical efficacy and safety
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c, body weight, hypoglycemia
Key secondary outcomes glycoalbumin, 1, 5-anhydroglucitol, blood pressure, lipids, insulin, proinsulin, adiponectin, leptin, CRP, bone metabolic markers, durability, safety

Base
Study type

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 Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sitagliptin
Interventions/Control_2 glimepiride
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes inadequately controlled with following therapies (HbA1c 6.9~10.4%)
1) diet and exercise therapy
2) treated with glinides or biguanides or pioglitazone monotherapy
3) treated with glinides and biguanides or pioglitazone (dual therapy)
Key exclusion criteria 1) kidney dysfunction (serum creatinine > 1.5 mg/dl in men, >1.3 mg/dl in women, or nephrotic syndrome)
2) heart failure, stroke
3) liver dysfunction (serum AST and/or ALT >100mU/ml or liver cirrhosis)
4) respiratory failure (needing oxygen therapy)
5) pregnant women
6) treated with sulfonyureas or alpha-glucosidase inhibitors
7) ketosis, diabetic coma, type 1 diabetes mellitus, severe infection
8) dementia
9) other inadequate patients



Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoichiro Nagasaka
Organization Jichi Medical University
Division name Division of Endocrinology and Metabolism
Zip code
Address Yakushiji 3311-1, Shimotsuke, Tochigi
TEL 81-285-58-7355
Email sngsk@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoichiro Nagasaka
Organization Jichi Medical University
Division name Division of Endocrinology and Metabolism
Zip code
Address Yakushiji 3311-1, Shimotsuke, Tochigi
TEL 81-285-58-7355
Homepage URL
Email sngsk@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization The Waksman Foundation of Japan INC
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 自治医科大学附属病院(栃木県)、あいそ内科(東京都)、やたがい内科クリニック(栃木県)、小山イーストクリニック(栃木県)、長崎病院(栃木県)、川井クリニック(茨城県)、いたばし糖尿病内科皮フ科クリニック(茨城県)、済生会宇都宮病院(栃木県)

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 18 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
2010 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 25 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 14 Day
Last modified on
2015 Year 05 Month 14 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020337

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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