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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008591
Receipt No. R000010093
Scientific Title Linagliptin study of effects on PPG,postprandial blood glucose control
Date of disclosure of the study information 2012/08/01
Last modified on 2015/06/24

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Basic information
Public title Linagliptin study of effects on PPG,postprandial blood glucose control
Acronym Linagliptin study of effects on PPG,postprandial blood glucose control
Scientific Title Linagliptin study of effects on PPG,postprandial blood glucose control
Scientific Title:Acronym Linagliptin study of effects on PPG,postprandial blood glucose control
Region
Japan

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

Objectives
Narrative objectives1 In this clinical study, we will compare the inhibitory effects of linagliptin on the postprandial blood glucose level and its beta-cell-function-improving effects (insulin secretion-improving effects) with those of a control drug, an beta-glucosidase inhibitor (voglibose) that has been used for many years as a first-choice drug at the start of drug therapy, to examine whether linagliptin has the potential to become a first-choice drug for type II diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A dietary tolerance test with a test meal will be conducted. Major evaluation items include the fasting blood glucose level early in the morning, its levels 2 hours after meals, and HbA1c at the start of administration (Week 0) and after 12 weeks.
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 Linagliptin treatment group(Group L)
Interventions/Control_2 Voglibose treatment group(Group B)
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.Drug na&iuml;ve patients of type 2 Diabetes (HbA1c (NGSP value) higher than 6.2 and below 9.4) in whom the target of blood glucose control specified in the 2010 diabetes treatment guidelines is not achieved despite dietary / exercise treatment including those after a 12-week or longer withdrawal of previous drug treatment for diabetes.
2.Twenty years of age or older, regardless of gender
3.Patient with good compliance
4.Written consent for participation in the study
Key exclusion criteria 1.Type I and secondary diabetes
2.Severe infectious disease, before or after surgery, and severe trauma
3.Events of myocardial infarction, angina pectoris, cerebral stroke, and cerebral infarction
4.Severe liver dysfunction (AST: 100 IU/l or higher)
5.Moderate or severer heart failure,
(NYHA/New York Heart Association stage III or severer)
6.Under treatment with diabetic drugs at the time of study initiation
7.Pregnant, lactating, and possibly pregnant women and those planning to become pregnant
8.Past medical history of hypersensitivity to investigational drugs
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 380

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HIROTAKA WATADA
Organization Juntendo University Graduate School of Medicine
Division name Department of Medicine, Metabolism and Endocrinology
Zip code
Address 2-1-1Hongo,Bunkyo-Ku,Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University Graduate School of Medicine
Division name Department of Medicine, Metabolism and Endocrinology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Japan society of Patient Reported Outcome
Institute
Department

Funding Source
Organization Japan society of Patient Reported Outcome
Organization
Division
Category of Funding Organization Other
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
2012 Year 08 Month 01 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
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 20 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
2012 Year 08 Month 01 Day
Last modified on
2015 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010093

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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