UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005178
Receipt No. R000006150
Scientific Title Efficacy of Sitagliptin added to sulfonylurea in subjects with poorly controlled type 2 diabetes (STRICT-1)
Date of disclosure of the study information 2011/03/09
Last modified on 2018/03/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy of Sitagliptin added to sulfonylurea in subjects with poorly controlled type 2 diabetes (STRICT-1)
Acronym SiTagliptin Randomized Intervention Clinical Trial- 1(STRICT-1)
Scientific Title Efficacy of Sitagliptin added to sulfonylurea in subjects with poorly controlled type 2 diabetes (STRICT-1)
Scientific Title:Acronym SiTagliptin Randomized Intervention Clinical Trial- 1(STRICT-1)
Region
Japan

Condition
Condition Type 2 Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate and compare the efficacy of sitagliptin on glycaemic control and pancreatic beta-cell function with alpha-glucosidase inhibitor in poorly controlled type 2 diabetes subjects with sulfonylurea
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Changes of HbA1c from baseline
Key secondary outcomes Fasted plasma glucose, Fasted serum insulin, Proinsulin-insulin ratio, and glucagon-induced CPR (changes from each baseline)
Compliance of treatment, Adverse effects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Sitagliptin treatment, 6 months
Interventions/Control_2 alpha-glucosidase inhibitor treatment, 6 months
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
81 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetes patients with poorly glycaemic control by sulfonylurea therapy

In this study, we defined "poorly glycaemic control by sulfonylurea" as bellow.

Dose of sulfonylurea: Recommemded doses by the Committee for "Reasonable use of GLP-1 analogues and DPP-4 inhibitors"
Duration of sulfonylurea: current dose for over 3 months
HbA1c keeps
1. 6.5% or more than 6.5%
2. Once below 6.5%, exceed 6.5% again
in current 3 months' observation.
HbA1c in the registration is within 6.5-8.5%
Concomitant oral antidiabetic drugs: TZDs or BGs are eligible
Key exclusion criteria 1.Contraindication for sitagliptin
2.Contraindication for alpha-glucosidase inhibitors
3.Patients treated with insulin
4.Pregnant or possible pregnant
5.Patients with severe liver failure or renal failure
6.Patients considered not eligible for the study by the attending doctor due to other reasons
7.Patients with past history of treatment of sitagliptin or other incretin related drugs
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Araki
Organization Department of Metabolic Medicine, Faculty of Life Science, Kumamoto University
Division name Department of Metabolic Medicine, Faculty of Life Science, Kumamoto University
Zip code
Address 1-1-1 Honjo, Kumamoto, 860-8556, Japan
TEL 096-373-5169
Email asano@phrf.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junji Kawashima
Organization Department of Metabolic Medicine, Faculty of Life Science, Kumamoto University
Division name Department of Metabolic Medicine, Faculty of Life Science, Kumamoto University
Zip code
Address 1-1-1 Honjo, Kumamoto, 860-8556, Japan
TEL 096-373-5169
Homepage URL
Email jkawashima@fc.kuh.kumamoto-u.ac.jp

Sponsor
Institute STRICT study Group
Institute
Department

Funding Source
Organization Public Health Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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 熊本大学医学部附属病院(熊本県),九州大学病院(福岡県),久留米大学病院(福岡県),産業医科大学病院(福岡県),佐賀大学医学部附属病院(佐賀県),長崎大学病院(長崎県),大分大学医学部附属病院(大分県),宮崎大学医学部附属病院(宮崎県),琉球大学医学部附属病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 09 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
2011 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2013 Year 11 Month 30 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 03 Month 03 Day
Last modified on
2018 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006150

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.