UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of Single tablet of fixed dose Mitiglinide and Voglibose or Linagliptine with Insulin Degludec.
Title of the study (Brief title)	The effect of Single tablet of fixed dose Mitiglinide and Voglibose or Linagliptine with Insulin Degludec.
Region	Japan

Condition
Condition	Type 2 Diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Although both Single tablet of fixed dose mitiglinide and voglibose (M+V) and Linagliptine (L) can improve postprandial hyperglycemia, there are a few repot about the combination of basal insulin therapy and those oral hypoglycemic agents (OHAs). In this study, we'll investigate the effect of combination therapy of the M+V or L with Insulin Degludec and also compare the effects for postprandial hyperglycemia after taking a test meal and a low carbohydrate meal.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Area Under the Curve of postprandial glucose levels after taking a test meal.
Key secondary outcomes	The Area Under the Curve of postprandial glucose levels after taking a low carbohydrate diet. HbA1c, GA, and 1,5-AG.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of single tablet of fixed dose mitiglinide (10 mg) and voglibose (0.2 mg) (three times a day) for 1-8 weeks and administration of linagliptin (5mg) (once a day) for 9-16 weeks with basal therapy of Insulin Degludec.
Interventions/Control_2	Administration of linagliptin (5mg) (once a day) for 1-8 weeks and administration of single tablet of fixed dose mitiglinide (10 mg) and voglibose (0.2 mg) (three times a day) for 9-16 weeks with basal therapy of Insulin Degludec.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes patients treated with insulin therapy and their HbA1c are less than 8.5%.
Key exclusion criteria	Patients with severe renal dysfunction, severe liver dysfunction, type 1diabetes, glutamic acid decarboxylase antibody positivity, malignancy, or other causes of hyperglycemia.
Target sample size	20

Research contact person
Name of lead principal investigator	Mitsuhiko Noda
Organization	National Center for Global Health and Medicine
Division name	Depertment of Diabetes Research
Address	1-21-1Toyama, Shinjukuku, Tokyo, Japan
TEL	03-3202-7181
Email	mnoda@hosp.ncgm.go.jp

Public contact
Name of contact person	Noriko Ihana
Organization	National Center for Global Health and Medicine
Division name	Depertment of Diabetes, Metabolism, and Endocrinology
Address	1-21-1Toyama, Shinjukuku, Tokyo, Japan
TEL	03-3202-7181
Homepage URL
Email	nori_3373@yahoo.co.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 04 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 20 Day
Anticipated trial start date	2014 Year 04 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 04 Month 10 Day
Last modified on	2016 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000015937