UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008469 |
|---|---|
| Receipt number | R000009959 |
| Scientific Title | Effects of beraprost sodium sustained-release tablet on improvement of insulin resistance in patients with type 2 diabetes with obesity in a Double-Blinded, Randomized, Placebo-Controlled, Crossover Trial. |
| Date of disclosure of the study information | 2012/07/18 |
| Last modified on | 2012/07/18 17:09:11 |
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Basic information
Public title
Effects of beraprost sodium sustained-release tablet on improvement of insulin resistance in patients with type 2 diabetes with obesity in a Double-Blinded, Randomized, Placebo-Controlled, Crossover Trial.
Acronym
Effects of beraprost sodium sustained-release tablet on improvement of insulin resistance in patients with type 2 diabetes with obesity.
Scientific Title
Effects of beraprost sodium sustained-release tablet on improvement of insulin resistance in patients with type 2 diabetes with obesity in a Double-Blinded, Randomized, Placebo-Controlled, Crossover Trial.
Scientific Title:Acronym
Effects of beraprost sodium sustained-release tablet on improvement of insulin resistance in patients with type 2 diabetes with obesity.
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes and obesity
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of beraprost sodium sustained-release tablets on improvement of insulin resistance during euglycemic hyperinsulinemic clamp, vascular endothelial function and glycemic control in patients with type 2 diabetes and obesity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the effects of beraprost sodium sustained-release tablets and placebo on the insulin resistance by glucose infusion rate on euglycemic hyperinsulinemic clamp
Key secondary outcomes
1. HOMA-IR (Homeostasis model assessment-Insulin Resistance)
To evaluate the effects on the insulin resistance.
2. Fasting blood glucose, Glycoalbumin, HbA1c
To evaluate the effects on the glycemic control.
3.ADMA, %FMD
To evaluate the effects on the vascular endotherial function.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Each subject will be followed for a run-in period of 4 weeks before being chosen at random for daily administration of ether beraprost sodium or a placebo with the same appearance of an alternative drug.
Each treatment period will last 8 weeks. The first 2 weeks consisted of 120ug/day beraprost sodium(2 sustained-release tablets)administered. The following 6 weeks consisted of 240ug/day beraprost sodium (4 sustained-release tablets) administered. There was a washout period of 4 weeks between placebo and beraprost sodium.
After 4 weeks of drug withdrawal, the The first 2 weeks of treatment consisted of placebo (2 tablets)administered. The following 6 weeks consisted of placebo(4 tablets) administered.
In last week of each treatment period, euglycemichyperinsulinemic
clamp (EHC)and Flow mediated dilation(FMD) will be performed.
Interventions/Control_2
Each subject will be followed for a run-in period of 4 weeks before being chosen at random for daily administration of ether beraprost sodium or a placebo with the same appearance of an alternative drug.
Each treatment period will last 8 weeks. The first 2 weeks consisted of placebo (2 tablets) administered. The following 6 weeks consisted of 240ug/day beraprost sodium (4 tablets) administered. There was a washout period of 4 weeks between placebo and beraprost sodium.
After 4 weeks of drug withdrawal, the The first 2 weeks of treatment consisted of 120ug/day beraprost sodium(2 sustained-release tablets)administered. The following 6 weeks consisted of 240ug/day beraprost sodium (4 sustained-release tablets) administered.
In last week of each treatment period, euglycemichyperinsulinemic
clamp (EHC)and Flow mediated dilation(FMD) will be performed.
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
Type 2 diabetes
HbA1c<8.4%
BMI>25
Key exclusion criteria
Patients with bleeding tendency
Patients with Type 1 diabetes or secondary diabetes
Patients with severe renal dysfunction
Patients with liver dysfunction
Patients with a past history if drug hypersensitivity
Pregnant women or women with breast-feeding
Patients who took prostaglandin derivatives within 3 months
Patients whose prescription drugs were changed within 3 months
All Patients who is unsuitable for this trial at a physician's discretion
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Kubota |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Department of Metabolic Diseases
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikiko Haraguchi |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Department of Metabolic Diseases
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
mikiko.haraguchi@gmail.com
Sponsor or person
Institute
Graduate School of Medicine, University of Tokyo
Department of Metabolic Diseases
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science & Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2012 | Year | 07 | Month | 18 | 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
| 2012 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 18 | Day |
Last modified on
| 2012 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009959
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