Unique ID issued by UMIN | UMIN000022953 |
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Receipt number | 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 18:24:02 |
The Study of INitial choice of DPP-4i in Japanese T2DM patients: Effects of Linagliptin on QOL
The Study of INitial choice of DPP-4i in Japanese T2DM patients: Effects of Linagliptin on QOL (INTEL-QOL study)
The Study of INitial choice of DPP-4i in Japanese T2DM patients: Effects of Linagliptin on QOL
The Study of INitial choice of DPP-4i in Japanese T2DM patients: Effects of Linagliptin on QOL (INTEL-QOL study)
Japan |
Type 2 Diabetes
Endocrinology and Metabolism |
Others
NO
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.
Safety,Efficacy
Change from baseline in OHA-Q score (total score) at the observation point of week 24
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Group A: Administer linagliptin
After randomization, patients in this group start linagliptin from 5 mg once a day for 24 weeks.
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%.
20 | years-old | <= |
75 | years-old | > |
Male and Female
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
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
44
1st name | |
Middle name | |
Last name | Hirotaka Watada |
Juntendo University Hospital
Department of Metabolism and Endocrinology
3-1-3 Hongo, Bunkyo-ku, Tokyo
03-3813-3111
hwatada@juntendo.ac.jp
1st name | |
Middle name | |
Last name | Hiroki Takayama |
Soiken Inc.
Clinical Study Support Division
NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
03-3295-1350
takayama@soiken.com
Juntendo University Hospital
1. Nippon Boehringer Ingelheim Co., Ltd.
2. Eli Lilly Japan K.K.
Profit organization
NO
2016 | Year | 07 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 06 | Month | 23 | Day |
2016 | Year | 09 | Month | 23 | Day |
2016 | Year | 06 | Month | 30 | Day |
2019 | Year | 03 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026448
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