UMIN-CTR Clinical Trial

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
Email	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
Email	soumu@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	Naga Municipal Hospital
Address	1282 Uchita, Kinokawa City, Wakayama 649-6414, Japan
Tel	0736772019
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012329