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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010880
Receipt No. R000012735
Scientific Title Effect of Linagliptin on daily glucose excursion in Continuous Glucose Monitoring of Type2 diabetic patients
Date of disclosure of the study information 2013/06/05
Last modified on 2018/06/11

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Basic information
Public title Effect of Linagliptin on daily glucose excursion in Continuous Glucose Monitoring of Type2 diabetic patients

Acronym L-CGM
Scientific Title Effect of Linagliptin on daily glucose excursion in Continuous Glucose Monitoring of Type2 diabetic patients

Scientific Title:Acronym 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
1st name
Middle name
Last name HIROAKI SATOH
Organization Fukushima Medical University
Division name Department of Nephrology, Hypertension, Diabetology, Endocrinology, and Metabolism
Zip code
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
1st name
Middle name
Last name Hiroki Takyama
Organization Soiken.inc
Division name Division of clinical study support
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 05 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 Completed
Date of protocol fixation
2013 Year 04 Month 10 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000012735

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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