UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008155 |
|---|---|
| Receipt number | R000009606 |
| Scientific Title | Effect of DPP-4 inhibitor or Metformin on insulin therapy in patients with type 2 diabetes |
| Date of disclosure of the study information | 2012/06/13 |
| Last modified on | 2013/06/13 13:17:17 |
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Basic information
Public title
Effect of DPP-4 inhibitor or Metformin on insulin therapy in patients with type 2 diabetes
Acronym
Effect of DPP-4 inhibitor or Metformin on insulin therapy in patients with type 2 diabetes
Scientific Title
Effect of DPP-4 inhibitor or Metformin on insulin therapy in patients with type 2 diabetes
Scientific Title:Acronym
Effect of DPP-4 inhibitor or Metformin on insulin therapy in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to examine effects of DPP-4 inhibitor "Sitagliptin" or biguanide "Metforimin" on glucose metabolism and it`s related factors (glucagon, C-peptide) in patients with type 2 diabetes who are inadequately controlled blood glucose level treated by insulin mono-therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of glucose, glucagon and C-peptide response to MTT after sitagliptin or metformin treatment.
Key secondary outcomes
Change of HbA1c, fasting plasma glucose, glucagon and C-peptide after sitagliptin or metforimin treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sitagliptin
Interventions/Control_2
metformin
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with type 2 daiabetes
2) Patients without change of treatment for the past three months
3) HbA1c(NGSP) 6.9%<=and10.5%>
4) Over 20 years old,Under 75 years old
5) A consent form for participating in this study is submitted
6) Possible to take the test meal (a set of Chicken in white sauce, crackers, soft pudding)
Key exclusion criteria
1) Patients with glucagnoma
2) Patients who started in the cure for the past three months
3) Patients who changed in the cure for the past three months
4) Patients with type 1 diabetes.Patients with type 2 diabetes HbA1c>=10.5% or severe ketosis,diabetic coma.
5) Patients treated with oral hypoglycemic agents
6) Patients with nephrosic syndrome
7) Patients treated with steroid, immune-suppressive agent and azole antifungal
8) Patients with allergy against sitagliptin and metformin
9)Patients with exceeding the moderate renal impairment (sCr: male>=1.3mg/dl, female>=1.2mg/dl).
10)Patients with exceeding the moderate liver dysfunction (AST,ALT>3 times upper standard value).
11)Patients who are pregnant, breast-feeding and/or intention to become pregnant
12)Other patients determined to be inappropriate by physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Nakazaki |
Organization
Itabashi Hospital, Nihon University School of Medicine
Division name
Divison of Diabetes and Metabolism
Zip code
Address
30-1 Oyaguchi kamicho, Itabashi-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Itabashi Hospital, Nihon University School of Medicine
Division name
Divison of Diabetes and Metabolism
Zip code
Address
30-1 Oyaguchi kamicho, Itabashi-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Divison of Diabetes and Metabolism,Itabashi Hospital, Nihon University School of Medicine
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
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
日本大学医学部附属板橋病院糖尿病代謝内科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 13 | 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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | 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
| 2012 | Year | 06 | Month | 13 | Day |
Last modified on
| 2013 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009606
