UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006401 |
|---|---|
| Receipt number | R000007569 |
| Scientific Title | Effect of sitagliptin on insulin secretion and glucose metabolism in Japanese patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2011/09/24 |
| Last modified on | 2012/11/15 15:47:49 |
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Basic information
Public title
Effect of sitagliptin on insulin secretion and glucose metabolism in Japanese patients with type 2 diabetes mellitus
Acronym
Effect of sitagliptin on insulin secretion and glucose metabolism in Japanese patients with type 2 diabetes mellitus
Scientific Title
Effect of sitagliptin on insulin secretion and glucose metabolism in Japanese patients with type 2 diabetes mellitus
Scientific Title:Acronym
Effect of sitagliptin on insulin secretion and glucose metabolism in Japanese patients with type 2 diabetes mellitus
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 change of glucose metabolism and insulin secretion after the administration of sitagliptin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change of glucose metabolism and insulin secretion evaluated with the use of stable isotope tracers and hyperglycemic clamp technique
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
examination with the use of stable isotope-labelled glucose
Interventions/Control_2
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
Japanese patients with hemoglobin A1c (JDS) level 6.5% and higher under antidiabetic treatment with lifestyle modification and/or oral hypoglycemic agents (sulfonylureas, biguanides, thiazolidinediones, and/or alpha-glucosidase inhibitors)
Key exclusion criteria
1) type 1 diabetes mellitus
2) history of severe ketosis, diabetic coma, or pre-coma within six months
3) severe infection, pre- or post-surgery, or severe trauma
4) renal dysfunction with serum creatinine >= 1.5 mg/dl in males or 1.3 mg/dl in females
5) body mass index >= 40 kg/m2
6) women who are pregnant, breast-feeding, or suspected of being pregnant
7) history of hypersensitivity to the investigational medication
8) patients whose participation in the current trial is evaluated as being inadequate by the doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Kaneto |
Organization
Osaka University Graduate School of Medicine
Division name
Depertment of Metabolic Medicine
Zip code
Address
2-2 Yamada-oka, Suita City, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Graduate School of Medicine
Division name
Depertment of Metabolic Medicine
Zip code
Address
2-2 Yamada-oka, Suita City, Osaka
TEL
Homepage URL
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MSD K.K
Organization
Division
Category of Funding Organization
Profit organization
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
| 2011 | Year | 09 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | 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
| 2011 | Year | 09 | Month | 24 | Day |
Last modified on
| 2012 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007569
| 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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