UMIN-CTR Clinical Trial

Public title

A study on whether fasting glucagon values affect the effect of DPP4 inhibitors on type 2 diabetic patients.

Acronym

Differences in clinical effect of DPP4 inhibitors due to differences in fasting glucagon.

Scientific Title

A study on whether fasting glucagon values affect the effect of DPP4 inhibitors on type 2 diabetic patients.

Scientific Title:Acronym

Differences in clinical effect of DPP4 inhibitors due to differences in fasting glucagon.

Region

Japan

Condition

Type 2 diabetes (insulin independent diabetes )

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In patients with type 2 diabetes, there are cases in which fasting glucagon is high and cases showing low value.In patients with type 2 diabetes, there are cases in which fasting glucagon is high and cases showing low value.The DPP-4 inhibitor is thought to suppress the secretion of glucagon, thereby bringing about blood glucose-improving action of diabetic patients. We investigate the hypothesis that DPP-4 inhibitor may differ in clinical effect due to glucagon value of type 2 diabetes.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Verification of difference in blood glucose improving effect of DPP-4 inhibitor in cases of type 2 diabetes with high or low fasting glucagon value.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Type 2 diabetes managed only by diet therapy and exercise therapy.
2. Type 2 diabetes who have undergone diabetes treatment with internal medicine but have not been treated with DPP-4 inhibitor or GLP-1 receptor agonist until now, or have undergone diabetes treatment with internal medicine, A case in which a DPP-4 inhibitor has been administered but the DPP-4 inhibitor has been discontinued and has been 6 months or more has passed.
3. A case corresponding to 1 and 2 above and HbA1 c <= 7.0%.

Key exclusion criteria

1. Cases of contraindications described in the package insert of sitagliptin
2. Cases during administration of DPP-4 inhibitor containing sitagliptin.
3. Cases during GLP-1 receptor agonist administration.
4. Patients treated with insulin (also switching to DPP-4 inhibitors)
5. Treating acute diseases.
6. Cases of malignant tumor complication and its history.
7. A case with moderate or higher renal dysfunction (Japanese estimated creatinine clearance <50 ml/min).
8. Liver function disorder associated with either AST (GOT) >100 IU/dl or ALT (GPT) >100 IU/dl
9. Pregnant women or women who may be pregnant.
10. A lactating woman.
11. A Case difficult to confirm whose intention.
12. Cases of complication of endocrine disorder.
13. A cases who uses drugs known to have side effects causing glucose metabolism (steroid drugs,Interferon etc) .
14. History of abdominal surgery.
15. Patients with metabolic incontinence symptoms associated with diabetes such as dry mouth, polydipsia, polyuria, nocturnal urine, and weight loss.
16. Cases with geriatric syndrome (sarcopenia, cognitive decline, ADL lowering etc).

Target sample size

20

Name of lead principal investigator

1st name	Raishi
Middle name
Last name	Ichikawa

Organization

Kitasato University School of Medicine

Division name

Department of Endcrinology, Diabetes and Metabolism

Zip code

252-0374

Address

1-15-1, Kitasato, Sagamihara-city, Minami-ku, Kanagawa, Japan

TEL

0427788111

Email

raizo@med.kitasato-u.ac.jp

Name of contact person

1st name	Raishi
Middle name
Last name	Ichikawa

Organization

Kitasato University School of Medicine

Division name

Department of Endcrinology, Diabetes and Metabolism

Zip code

252-0374

Address

1-15-1, Kitasato, Sagamihara-city, Minami-ku, Kanagawa, Japan

TEL

0427788111

Homepage URL

Email

raizo@med.kitasato-u.ac.jp

Institute

Kitasato University

Institute

Department

Personal name

Organization

Department of Endcrinology, Diabetes and Metabolism, Kitasato University, School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kitasato University Medical Ethics Organization (KMEO), Institutional Review Board for Clinical Research and Treatment

Address

Kitasato, Sagamihara-city, Minami-ku, Kanagawa, Japan

Tel

0427788273

Email

rinrib-n@kitasato-u.ac.jp

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

2018

Year

01

Month

17

Day

URL releasing protocol

This study was discontiued.

Publication of results

Unpublished

URL related to results and publications

This study was discontiued.

Number of participants that the trial has enrolled

2

Results

This study was discontinued.

Results date posted

2023

Year

01

Month

10

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

This study was discontinued.

Participant flow

This study was discontinued.

Adverse events

There were no adverse events for the included participants.

Outcome measures

This study was discontinued.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2018

Year

01

Month

17

Day

Date of IRB

2018

Year

03

Month

15

Day

Anticipated trial start date

2018

Year

04

Month

01

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

In the present study, fasting plasma glucagon is measured as a next test after incorporation at the next outpatient visit, and the group is divided into a group with a fasting glucagon value of less than 40 pg / ml and a group with more than 40 pg / ml. DPP-4 inhibitor is administered to each group after observation for 4 weeks from blood collection at the time of incorporation. After 4 weeks and 8 weeks from the start of administration of DPP-4 inhibitor, it was compared and analyzed whether indexes of diabetes management of each group improved from before administration of DPP-4 inhibitor, and DPP-4 We examine whether there are differences in clinical effects of inhibitors. In addition, fluctuation of fasting glucagon before and after administration of DPP-4 inhibitor is also analyzed.

Registered date

2018

Year

01

Month

05

Day

Last modified on

2023

Year

01

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035046