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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022953
Receipt No. R000026448
Scientific Title The Study of INitial choice of DPP-4i in Japanese T2DM patients: Effects of Linagliptin on QOL
Date of disclosure of the study information 2016/07/01
Last modified on 2019/03/04

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Basic information
Public title The Study of INitial choice of DPP-4i in Japanese T2DM patients: Effects of Linagliptin on QOL
Acronym The Study of INitial choice of DPP-4i in Japanese T2DM patients: Effects of Linagliptin on QOL (INTEL-QOL study)
Scientific Title The Study of INitial choice of DPP-4i in Japanese T2DM patients: Effects of Linagliptin on QOL
Scientific Title:Acronym The Study of INitial choice of DPP-4i in Japanese T2DM patients: Effects of Linagliptin on QOL (INTEL-QOL study)
Region
Japan

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

Objectives
Narrative objectives1 The objective is to compare the QOL outcomes in patients with type 2 diabetes following the use of either a DPP-4 inhibitor, linagliptin or metformin by using QOL questionnaires. The effects of linagliptin on blood biomarkers, such as HbA1c, are also examined for the treatment effects and safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change from baseline in OHA-Q score (total score) at the observation point of week 24
Key secondary outcomes The following outcomes from baseline to week 24 are evaluated:
1) OHA-Q, changed values of each domain score

2) Changed value of DTR-QOL (total score, each domain score)

3) Changed value of HbA1c

4) Prevalence of the patients (%) achieved the target HbA1c level (HbA1c< 6.0%, HbA1c< 7.0%, or HbA1c improved 0.5% or more)

5) Changed value of glucose level at fasting state

6) Prevalence of the patients (%) achieved HbA1c< 7.0% and improved their QOL scores

7) Incidence rate of hypoglycemia

8) Incidence rate of adverse events found in digestive system (diarrhea, nausea, vomiting)

9) Hospitalization (%) due to heart failure

10) Incidence rate of other adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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: Administer linagliptin
After randomization, patients in this group start linagliptin from 5 mg once a day for 24 weeks.
Interventions/Control_2 Group B: Administer metformin
After randomization, patients in this group start with metformin twice or three times per day of total 500 mg, and adjust the amount during the 24 week period, aiming for HbA1c below 7%.

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
75 years-old >
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria are included in this study.
1. Japanese patients with type 2 diabetes who have not achieved the target blood glucose level that is specified in the Treatment Guide for Diabetes 2014-2015 [HbA1c (NGSP) level of 6.0% or higher]

2. Patients newly starting diabetic treatment with an oral antidiabetic drug in addition to diet and exercise therapies

3. Patients who were 20-year old or older, and younger than 75-year old at the time of consent

4. Patients who can consent in writing
Key exclusion criteria Patients who fall into any of the following criteria are excluded from participating in the study.
1. Patients with type 1 diabetes or secondary diabetes

2. Patients show an acute diabetic complication within 6 weeks before consenting to participate in the study

3. Patients with congestive heart failure or myocardial infarction requiring drug therapy

4. Patients with unstable angina and those who underwent coronary artery bypass surgery within 6 months before consent was acquired

5. Patients with hepatic cirrhosis or chronic active hepatitis

6. Patients with moderate to severe renal dysfunction and undergoing dialysis

7. Patients with ALT or AST levels that are at least 3-fold higher than the reference levels (>=3 X ULN)

8. Direct bilirubin levels at least 3-fold higher than the reference levels (>=3 X ULN), with clinically significant changes in TSH levels, or with fasting triglyceride levels of >7.9 mmol/l

9. Patients who have previously used an antidiabetic drug

10. Patients with dementia or with probable dementia and those with a psychiatric illness

11. Patients who lack the ability to make judgments and those who are unable to read and write

12. Patients requiring a legally acceptable representative

13. Patients who are or may be pregnant, or breastfeeding

14. If the study drug is contraindicated to use

15. Patients with a malignant tumor or a history of a malignant tumor (however, patients who are not currently undergoing treatment for a malignant tumor and who do not appear and are not likely to have any recurrence during the study period may be included.)

16. Other conditions that are considered inappropriate to participate by the investigators

Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotaka Watada
Organization Juntendo University Hospital
Division name Department of Metabolism and Endocrinology
Zip code
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email hwatada@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code
Address NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL 03-3295-1350
Homepage URL
Email takayama@soiken.com

Sponsor
Institute Juntendo University Hospital
Institute
Department

Funding Source
Organization 1. Nippon Boehringer Ingelheim Co., Ltd.
2. 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
2016 Year 07 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
2016 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 23 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
2016 Year 06 Month 30 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026448

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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