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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010543
Receipt No. 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 2013/04/19

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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
Middle name
Last name Akira Kawashima
Organization Naga Municipal Hospital
Division name Department of Internal Medicine
Zip code
Address 1282 Uchita, Kinokawa City, 1282 Uchita, Kinokawa City, Wakayama 649-6414, Japan
TEL 0736-77-2019
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsushi Nasu
Organization Naga Municipal Hospital
Division name Department of Internal Medicine
Zip code
Address 1282 Uchita, Kinokawa City, Wakayama 649-6414, Japan
TEL 0736-77-2019
Homepage URL
Email t.nasu@nagahp.jp

Sponsor
Institute Naga Municipal Hospital
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2013 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 22 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
2013 Year 04 Month 19 Day
Last modified on
2013 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012329

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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