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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005508
Receipt No. R000004943
Scientific Title Effects of sitaglyptin 100mg on glucose cotrol in patients with type2 diabetes compared with sitaglyptin 50mg with sulphonylurea or alpha-glucosidase inhibitor
Date of disclosure of the study information 2011/04/26
Last modified on 2012/04/25

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Basic information
Public title Effects of sitaglyptin 100mg on glucose cotrol in patients with type2 diabetes compared with sitaglyptin 50mg with sulphonylurea or alpha-glucosidase inhibitor
Acronym Treatment of type2 diabetic patients with sitaglyptin or sitaglyptin with sulphonylurea or alpha-glucosidase inhibitor
Scientific Title Effects of sitaglyptin 100mg on glucose cotrol in patients with type2 diabetes compared with sitaglyptin 50mg with sulphonylurea or alpha-glucosidase inhibitor
Scientific Title:Acronym Treatment of type2 diabetic patients with sitaglyptin or sitaglyptin with sulphonylurea or alpha-glucosidase inhibitor
Region
Japan

Condition
Condition type2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effects of sitaglyptin on glucose control and endothelial function in patients with type2 diabetes and compare with sitaglyptin with sulphonylurea or alpha-glucosidase inhibitor
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes glucose control
Key secondary outcomes endothelial function, oxidative stress

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dose of sitaglyptin increased from 50mg/d to 100mg/d (3-month administration)
Interventions/Control_2 Glimepiride 1m/d add to sitaglyptin 50mg/d (3-month administration)
Interventions/Control_3 Acarbose 300mg/d or voglibose 0.6mg/d add to sitaglyptin 50mg/d (3-month administration)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Diabetic patients who administrated sitaglyptin 50mg/d for 3 months or more, and still poor control of plasma glucose.
Key exclusion criteria 1. Pregnant or lactating women
2. Diabetes mellitus patients with unstable glycemic control whose HbA1c is more than 8.0%. Or complicated with diabetic nephropathy more than stage3.
3. Patient who is intolerate or allergic againts sitaglyptin, glimepiride, acarbose or voglibose
4. Patient who has kidney or liver dysfunction
5. Type 1 diabetes mellitus
6. Patient who suffered from ketoacidosis or diabetic coma during 3 months. Or patient who has a history of deep coma.
7. Patient who has a severe infection, an operation, or severe injury.
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyu Takeda
Organization Kanazawa University Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 13-1 Takara-machi
TEL 076-265-2252
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyu Takeda
Organization Kanazawa University Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 13-1 Takara-machi
TEL 076-265-2252
Homepage URL
Email

Sponsor
Institute Department of Internal Medicine, Graduate School of Medical Science, Kanazawa University
Institute
Department

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
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 金沢大学附属病院(石川県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 26 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 Preinitiation
Date of protocol fixation
2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2012 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 25 Day
Last modified on
2012 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004943

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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