UMIN-CTR Clinical Trial

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

Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Juntendo University Hospital

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

06

Month

30

Day

Last modified on

2019

Year

03

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026448