UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Linagliptin on daily glucose excursion in Continuous Glucose Monitoring of Type2 diabetic patients
Title of the study (Brief title)	L-CGM
Region	Japan

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

Objectives
Narrative objectives1	It has been no reported that the studies in the circadian glycemic profile of Linagliptin using continuous glucose monitoring (CGM) in Japanese Type 2 diabetic patients. In this clinical study, we investigate whether Linagliptin, the first biliary excreted type selective DPP-4 inhibitor (1 dose), improves the change of mean 24 hours glucose level at the point of 12 weeks from Baseline in comparison with Alfa-glycosidase inhibitor that has been in use for many years as first-line treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of mean 24 hours glucose level at the point of 12 weeks from Baseline
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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	Group A; patients who take Linagliptin
Interventions/Control_2	Group B; patients who take Voglibose
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients with type 2 diabetes have not been taken antidiabetic medication more than 12 week. 2.7.4% and higher -HbA1c- under 10% (NGSP) at screening. 3.18 over - BMI under 30 4.eGFR,45 or higher 5.Twenty years of age or older, regardless of gender 6.Written consent for participation in the study
Key exclusion criteria	1.Type 1 and secondary diabetes 2.Severe infectious disease, before or after surgery, and severe trauma 3.Events of myocardial infarction, cerebral stroke, cerebral infarction and TIA in the past 3 month. 4.Moderate or severer heart failure(NYHA/New York Heart Association stage III or severer) 5.Severe liver dysfunction (ALT,AST and ALP face 3 times the normal level) 6.Past medical history of hypersensitivity to investigational drugs. 7.Patients addicted to alcohol and drugs. 8.Pregnant, lactating, and possibly pregnant women and those planning to become pregnant. 9.Patients with cancer. 10.Patent receiving steroid therapy with inflammatory affection. 11.Past medical history of abdominal operation and ileus. 12.Judged as ineligible by clinical investigators.
Target sample size	100

Research contact person
Name of lead principal investigator	HIROAKI SATOH
Organization	Fukushima Medical University
Division name	Department of Nephrology, Hypertension, Diabetology, Endocrinology, and Metabolism
Address	1 Hikarigaoka Fukushima-city, Fukushima, 960-1295, Japan
TEL	024-547-1206
Email	hiroakis-tky@umin.ac.jp

Public contact
Name of contact person	Hiroki Takyama
Organization	Soiken.inc
Division name	Division of clinical study support
Address	NBF OGAWAMACHI BUILDING 4F, 1-3-1,Kanda Ogawamachi, Chiyoda-ku, Tokyo
TEL	03-3295-1350
Homepage URL
Email	takayama@soiken.com

Sponsor
Institute	Japan society of Patient Reported Outcome
Institute
Department

Funding Source
Organization	Nippon Boehringer Ingelheim Co ., Ltd and Eli Lilly Japan K.K
Organization
Division
Category of Funding Organization	Profit organization
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	2013 Year 06 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 10 Day
Anticipated trial start date	2013 Year 07 Month 01 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	2013 Year 06 Month 05 Day
Last modified on	2018 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012735