UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005471 |
|---|---|
| Receipt number | R000006489 |
| Scientific Title | Comparison of efficacy between DPP-4 inhibitor up-titration vs addition of acarbose in T2DM |
| Date of disclosure of the study information | 2011/05/02 |
| Last modified on | 2013/09/25 19:41:29 |
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Basic information
Public title
Comparison of efficacy between
DPP-4 inhibitor up-titration vs addition of acarbose
in T2DM
Acronym
Clinical study of combination therapy with Acarbose and DPP-4 inhibitor
Scientific Title
Comparison of efficacy between
DPP-4 inhibitor up-titration vs addition of acarbose
in T2DM
Scientific Title:Acronym
Clinical study of combination therapy with Acarbose and DPP-4 inhibitor
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 evaluate the effect of acarbose in combination with DPP-4 inhibitor (sitagliptin) on metabolic control in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lipid profile(pre-and post-meal(30min,1,2hours)triglyceride, pre- and post-meal(30min,1,2hours)chylomicron, pre- and post-meal(30min,1,2hours)VLDL, pre- and post-meal(30min,1,2hours)IDL, pre- and post-meal(30min,1,2hours)native LDL, pre- and post-meal(30min,1,2hours)small dense LDL, pre- and post-meal(30min,1,2hours)HDL
Key secondary outcomes
HbA1c, The blood glucose, insulin, proinsulin, GLP-1, GIP, glucagon level are measured before as well as after 0.5, 1, 2 hour after breakfast.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
Acarbose 150-300mg/day for 3 months
Interventions/Control_2
Sitagliptin 100mg/day for 3 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Type 2 Diabetes mellitus (HbA1c level: more than 6.5%, less than 10.0%)
2) Age more than 20 years
3) Patients who have been taking 50mg qd of sitagliptin for 3 months or more (50mg qd: half of approved maximum dose)
4) 2hr postprandial glucose levels: more than 200mg/dL
5) Fasting TG levels: more than 150mg/dL
6) Pts with written IC
Key exclusion criteria
1) According to package insert descriptions (Severe ketosis, diabetic coma etc.)
2) Patients who use of other antidiabetic agents
3) Patients who use of fibrate
4) Gastrointestinal discomfort
5) Severe hepatic dysfunction or severe renal dysfunction
6) Patients judged by the investigator to be ineligible for some other reason
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Inoue |
Organization
Saitama Medical University
Division name
Dept. of Endocrinology and Diabetology
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1875
i1901018@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuo Inoue |
Organization
Saitama Medical University
Division name
Dept. of Endocrinology and Diabetology
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1875
Homepage URL
i1901018@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kumagaya Geka Hospita
Name of secondary funder(s)
None
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
熊谷外科病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 20 | Day |
Last modified on
| 2013 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006489
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
