UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013356 |
|---|---|
| Receipt number | R000015584 |
| Scientific Title | Effects of DPP4 inhibitor, sitagliptin or Sulfonylurea on intrahepatic adipose mass and lipid metabolism in patients with type 2 diabetes accompanied by fatty liver : a prospective randomized, open-label trial |
| Date of disclosure of the study information | 2014/03/06 |
| Last modified on | 2017/02/17 08:37:55 |
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Basic information
Public title
Effects of DPP4 inhibitor, sitagliptin or Sulfonylurea on intrahepatic adipose mass and lipid metabolism in patients with type 2 diabetes accompanied by fatty liver : a prospective randomized, open-label trial
Acronym
Sitagliptin Effect on fatty liver and Lipid Metabolism study
Scientific Title
Effects of DPP4 inhibitor, sitagliptin or Sulfonylurea on intrahepatic adipose mass and lipid metabolism in patients with type 2 diabetes accompanied by fatty liver : a prospective randomized, open-label trial
Scientific Title:Acronym
Sitagliptin Effect on fatty liver and Lipid Metabolism study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare effects of DPP4 inhibitor, sitagliptin and Sulfonylurea on intrahepatic adipose mass and lipid metabolism and fatty mass in patients with type 2 diabetes accompanied by fatty liver .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
amount of Intrahepatic adipose mass and visceral fat(MRI,DEXA)
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
NO
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
sitagliptin administration group
Interventions/Control_2
Glimepiride administration group
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Inadequately controlled type 2 diabetic patients who are not taking antidiabetic agent other than metformin for more than 2 month. Patients whose HbA1c ranges from 6.9% to 9.4%.
2)Patients who had Fatty liver, or Patients whose IHL(intrahepatic lipid content)is more than 10% on 1H-MRS, or Patients who had metabolic syndrome fulfilled the diagnostic criteria, or Patients whose BMI is more than 25.
3)Patients who have been received diabetes treatment for more than 6 months.
4)over 20 years age
5)Out patient
6)Gender is not restricted.
7)Patient understands study procedures and agrees to participate in the study by giving written informed consent prior to the study start.
Key exclusion criteria
1)Patients who had diabetic ketosis, or diabetic pre-coma and coma within 6 months of the study entry.
2)Patients with severe infections, before or after operation, or with serious trauma.
3)Patients with pregnancy, possibility of pregnancy or having a breast feeding.
4)Patients with renal insufficiency (serum creatinine = and > 1.5 mg/dl)
5)Patients who received insulin therapy.
6)Patients who administered antihyperlipidemic agent other than Metformin for observation period.
7)Patients who had a history of hypersensitive reaction to DPP-4 inhibitor.
8)Patients whom the attending doctor estimated to be ineligible according to the medical rationale.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Tanaka |
Organization
St.Marianna University School of Medicine
Division name
Division of Endocrinology and Metabolism
Zip code
Address
2-16-1
TEL
044-977-8111
h.k.kato@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kato |
Organization
St.Marianna University School of Medicine Hospital
Division name
Division of Endocrinology and Metabolism
Zip code
Address
2-16-1 Sugou, Miyamae-ku Kawasaki-city Kanagawa-ken
TEL
044-977-8111
Homepage URL
y2tanaka@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Diabetes Mellitus Square
Organization
Division
Category of Funding Organization
Other
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
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 31 | 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
| 2014 | Year | 03 | Month | 06 | Day |
Last modified on
| 2017 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015584
