UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008591 |
|---|---|
| Receipt number | 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 20:03:05 |
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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 naïve 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
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
Sponsor or person
Institute
Japan society of Patient Reported Outcome
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010093
