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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005471
Receipt No. 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

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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
Email 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
Email i1901018@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006489

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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