UMIN-CTR Clinical Trial

Public title

Investigation of maintenance of efficacy for 24 hours after teneligliptin administration, and the mechanism of action.

Acronym

Investigation of maintenance of efficacy for 24 hours after teneligliptin administration, and the mechanism of action.

Scientific Title

Investigation of maintenance of efficacy for 24 hours after teneligliptin administration, and the mechanism of action.

Scientific Title:Acronym

Investigation of maintenance of efficacy for 24 hours after teneligliptin administration, and the mechanism of action.

Region

Japan

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess that tenerigliptin can control the postprandial blood glucose 24 hours after administration in patients with type 2 diabetes.
To confirm the efficacy of teneligliptin administration with type-2 diabetes patients who require glucotoxicity elimination, when glucotoxicity has been eliminated as far as possible using insulin, etc. (Glucotoxicity is considered to have been eliminated as far as possible when the fasting blood sugar concentration is 126 mg/dL or less.)

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Active GLP1 concentration
Total and active GIP concentration
Change in postprandial glucose( For 5 days)
Change in HbA1c(For 3 months)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Taking the teneligliptin 20mg/day

Interventions/Control_2

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients who have given written informed consent for participation in this study.
2)Patients can be of either sex.
3)Patients must be at least 20 years old on the date of giving informed consent.
4) Patients must not have taken thiazolidinediones or dipeptidyl peptidase-4 -inhibitors within 3 months before admission to hospital or later. However, other antidiabetic agents are not problematic.
5) At admission to hospital, patients must have a glycosylated hemoglobin (HbA1c) level, as defined by the National Institutes of Diabetes and Digestive and Kidney Diseases, of 6.9% to 10.4%. At admission to hospital, patients must have had diabetes for less than 10 years.
6) In the case of patients with whom glucotoxicity has been eliminated as far as possible, using rapid-acting insulin, ultra-rapid-acting insulin, or sulfonylurea agents, and who thus have fasting blood sugar levels of 126 mg/dL or lower, the blood sugar level 2 hours after a meal must be at least 180 mg/dL.

Key exclusion criteria

1)Patients with type-1 diabetes; diabetes due to pancreatic disorder; or secondary diabetes, due to Cushings syndrome, acromegaly, etc.
2)Patients to whom the contraindications in the Package Insert apply.
3)Patients are classed as having excessive alcohol consumption if their mean daily intake of pure alcohol is 60 g or higher, this being equivalent to three cups of sake, one cup of shochu (a Japanese spirit), three medium-sized bottles of beer, three whiskey or brandy doubles, or five glasses of wine.
4)Patients who are or may be pregnant, or are breastfeeding.
5) Patients whose participation in the study is judged by the Investigator or Sub-Investigator to be inappropriate for any other reason.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Jun-ichiro Miyagawa

Organization

Hyogo college of medicine

Division name

Dept. of Diabetes, Endocrinology and Metabolism

Zip code

Address

1-1,mukogawa-cho,Nishinomiya-shi,hyogo

TEL

0798-45-6592

Email

miyagawa@hyo-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Jun-ichiro Miyagawa

Organization

Hyogo college of medicine

Division name

Dept. of Diabetes, Endocrinology and Metabolism

Zip code

Address

1-1,mukogawa-cho,Nishinomiya-shi,hyogo

TEL

0798-45-6592

Homepage URL

Email

miyagawa@hyo-med.ac.jp

Institute

Hyogo college of medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2013

Year

08

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

Open public recruiting

Date of protocol fixation

2012

Year

12

Month

18

Day

Date of IRB

Anticipated trial start date

2013

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

07

Month

30

Day

Last modified on

2014

Year

02

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013256