UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012262 |
|---|---|
| Receipt number | R000014327 |
| Scientific Title | Comparison study of the effects between DPP-4 inhibitor and sulfonylurea on glucagon secretion in type 2 diabetic patients treated with biguanide |
| Date of disclosure of the study information | 2013/11/20 |
| Last modified on | 2013/11/11 14:03:21 |
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Basic information
Public title
Comparison study of the effects between DPP-4 inhibitor and sulfonylurea on glucagon secretion in type 2 diabetic patients treated with biguanide
Acronym
DPP-4 inhibitor and sulfonylurea on glucagon secretion in type 2 diabetic patients treated with biguanide
Scientific Title
Comparison study of the effects between DPP-4 inhibitor and sulfonylurea on glucagon secretion in type 2 diabetic patients treated with biguanide
Scientific Title:Acronym
DPP-4 inhibitor and sulfonylurea on glucagon secretion in type 2 diabetic patients treated with biguanide
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study was designed to investigate the effects between DPP-4 inhibitor and sulfonylurea on glucagon secretion in type 2 diabetic patients treated with biguanide
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
blood glucose, plasma insulin,plasma glucagon
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
alogliptin
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Type 2 diabtes
2)No change in therapy with oral antidiabetes agent at least 3 months
3)HbA1c: 7.0-8.5%,,treated with metformin
4)age: 20 - 75 years
5)made a written informed consent
6))patients who do not have an allergy to test meal
Key exclusion criteria
1)iabets mellitus due to glucagon-producing tumor
2) patients:the medicine is changed within the last three months
3) Type 1 diabtes,HbA1c: higher than 10.5%,patients who require hospitalization for high blood glucose or diabetic ketoasidosis
4) patients treated with Dpp-4 inhibitor, sulfonylurea or insulin injection
5)patients with nephrotic syndrome
6) hypersensitivity to drugs on this study
7) renal dysfunction (1.3 and 1.2 mg/dL or more for male and female, respectively)
8)hepatitis (AST,ALT: three folds higher than baseline),
9) pregnancy, possibly pregnant woman
10) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suguru Yamaguchi |
Organization
Itabashi Hospital, Nihon University School of Medicine
Division name
Divison of Diabetes and Metabolism
Zip code
Address
30-1 Oyaguchi kamicho, Itabashi-ku, Tokyo
TEL
0339728111
yamaguchi.suguru@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suguru Yamaguchi |
Organization
Itabashi Hospital, Nihon University School of Medicine
Division name
Divison of Diabetes and Metabolism
Zip code
Address
30-1 Oyaguchi kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
yamaguchi.suguru@nihon-u.ac.jp
Sponsor or person
Institute
Divison of Diabetes and Metabolism,Itabashi Hospital, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Divison of Diabetes and Metabolism,Itabashi Hospital, Nihon University School of Medicine
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
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
| 2013 | Year | 11 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 11 | Day |
Last modified on
| 2013 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014327
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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