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 UMIN000004674
Receipt No. R000005463
Scientific Title Examine the comparative availability of DPP-4 Inhibitor versus Alfa-glycosidase inhibitor for the type 2 diabetic patient who was treated with Sulfonylurea
Date of disclosure of the study information 2010/12/07
Last modified on 2013/06/29

* 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 Examine the comparative availability of DPP-4 Inhibitor versus Alfa-glycosidase inhibitor for the type 2 diabetic patient who was treated with Sulfonylurea
Acronym Study for an ultimate combination therapy to control diabetes with Sitagliptin-2
Scientific Title Examine the comparative availability of DPP-4 Inhibitor versus Alfa-glycosidase inhibitor for the type 2 diabetic patient who was treated with Sulfonylurea
Scientific Title:Acronym Study for an ultimate combination therapy to control diabetes with Sitagliptin-2
Region
Japan

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

Objectives
Narrative objectives1 Examine the comparative availability of DPP-4 Inhibitor, Sitagliptin versus Alfa-glycosidase inhibitor for the type 2 diabetic patient who responded suboptimal glycemic control with Sulfonylurea alone.
Basic objectives2 Others
Basic objectives -Others Examine the clinical availability on Sitagliptin by comparing the lipid metabolism, oxidative-stress marker and tolerability.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Change of HbA1c from the baseline to 12 weeks later
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 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 Sulfonylurea (glimepiride) + Stagliptin
Interventions/Control_2 Sulfonylurea (glimepiride) + Alpha-Glycosidase inhibitor
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients with type 2 diabetes
2)Patients with suboptimal glycemic control by glimepiride 2mg/day for more than 2 months treatments.
3)Age >=20 years, <80 years (Male and Female)
4)A consent form for participating in this study is submitted
Key exclusion criteria 1)Patients with type 1 diabetes
2)History of severe ketosis, diabetic coma or precoma within 6 months
3)Patients with severe infections, before or after operation, or with serious trauma
4)Patients with exceeding the moderate renal impairment
5)Patients with history of stroke, MI or other sever vascular complication which required a hospitalization within six months.
6)Patients receiving DPP-4 Inhibitor except Sitagliptin
7)Patients receiving Alfa-glycosidase inhibitor, Sulfonylurea or Glinide during obtaining the informed consent or received Insulin treatment in the past 2 months.
Patients receiving alfa-glucosidase inhibitor or suruhoniyl urea or glinide at getting the informed consent or recieving Insulin within 2 months
8)Patients receiving glimepiride more than 2mg/day at getting the informed concent
9)Patients who are pregnant, breastfeeding or intention to becoming pregnant
10)Having allergy to DPP-4 Inhibitor or alfa-glucosidase inhibitor
11)Other patients determined to be inappropriate by physician
Target sample size 114

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kotaro Yokote
Organization Graduate School of Medicine, Chiba University
Division name Clinical Cell Biology and Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, 260-8670, Chiba-city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine, Chiba University
Division name Clinical Cell Biology and Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, 260-8670, Chiba-city
TEL
Homepage URL
Email

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Waksman Financial Group
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

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 07 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 11 Month 17 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2012 Year 08 Month 10 Day
Date of closure to data entry
Date trial data considered complete
2012 Year 10 Month 14 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 07 Day
Last modified on
2013 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005463

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.