UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010543 |
|---|---|
| Receipt number | R000012329 |
| Scientific Title | Comparison of metformin and vildagliptin in type 2 diabetes assessed by meal tolerance test |
| Date of disclosure of the study information | 2013/04/22 |
| Last modified on | 2020/10/29 13:37:37 |
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Basic information
Public title
Comparison of metformin and vildagliptin in type 2 diabetes assessed by meal tolerance test
Acronym
Comparison of metformin and vildagliptin in type 2 diabetes assessed by meal tolerance test
Scientific Title
Comparison of metformin and vildagliptin in type 2 diabetes assessed by meal tolerance test
Scientific Title:Acronym
Comparison of metformin and vildagliptin in type 2 diabetes assessed by meal tolerance test
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 metformin and vildagliptin for efficacy in type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of glucose variability between two treatments by Meal Tolerance Test
Key secondary outcomes
Comparison of serum C-peptide and glucagon levels between two treatments
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Hospitalized patients with type 2 diabetes under insulin therapy or oral diabetic agents treatment will be enrolled. Insulin secretion will be evaluated by glucagon test prior to the treatments for this study to exclude the subjects without enough capacity of insulin secretion (deltaCPR <1.0ng/ml). After fasting blood glucose is controlled to the range from 80mg/dl to 130mg/dl (during pre observation period), either metformin (1000mg/day) or vildagliptin (100mg/day) will be administered to each patient for 3 days followed by MTT (First period).Then, the drug will be switched to another one for next 3 days followed by MTT (Second period). Finally, the combination of two drugs will be administered for last three days followed by MTT (Third period)
metformin 1000mg/day->vildagliptin 100mg/day
Interventions/Control_2
vildagliptin 100mg/day->metformin 1000mg/day
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
Patients with type 2 diabetes who meet the following conditions:
(1)Age: younger than 75 years old, elder than 20 years old
(2)recent HbA1c : less than 12.0%
Key exclusion criteria
Patients who falls under any of the following conditions shall be excluded:
(1)Type 1 diabetes or type 2 diabetes with insulin-dependent condition
(2)severe renal and liver dysfunction
(3)unstable pre or proliferative diabetic retinopathy, severe neuropathy
(4)past history of the gastrointestinal tract or pancreas operation
(5)administered steroid drugs
(6)severe infection
(7)pregnant or planned pregnant in the near future
(8)ineligible for some other medical reasons judged by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kawashima |
Organization
Naga Municipal Hospital
Division name
Department of Internal Medicine
Zip code
6496414
Address
1282 Uchita, Kinokawa City, 1282 Uchita, Kinokawa City, Wakayama 649-6414, Japan
TEL
0736-77-2019
soumu@nagahp.jp
Public contact
Name of contact person
| 1st name | Tetsushi |
| Middle name | |
| Last name | Nasu |
Organization
Naga Municipal Hospital
Division name
Department of Internal Medicine
Zip code
649-6414
Address
1282 Uchita, Kinokawa City, Wakayama 649-6414, Japan
TEL
0736772019
Homepage URL
soumu@nagahp.jp
Sponsor or person
Institute
Naga Municipal Hospital
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
Naga Municipal Hospital
Address
1282 Uchita, Kinokawa City, Wakayama 649-6414, Japan
Tel
0736772019
soumu@nagahp.jp
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
公立那賀病院 内科 Department of Internal Medicine, Naga Municipal Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 22 | 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
| 2013 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 19 | Day |
Last modified on
| 2020 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012329
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
