UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038459
Receipt number R000043558
Scientific Title To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes
Date of disclosure of the study information 2019/11/01
Last modified on 2021/11/06 00:17:48

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Basic information

Public title

To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes

Acronym

To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes

Scientific Title

To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes

Scientific Title:Acronym

To evaluate the efficacy and safety of sitagliptin for the long-term treatment of type 2 diabetes

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of sitagliptin for 10 years and to discuss the differences between using sitagliptin and unusing DPP-4 inhibitors.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fasting blood glucose and HbA1c are set to be measured at baseline and once at 3 months for 10 years.

Key secondary outcomes

Body Mass Index (BMI), blood pressure, albumine creatinine ratio (ACR), lipid and liver function are set to be measured at baseline and once at 3 months for 10 years.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


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

Active treatment with sitagliptin 50mg/day for 10 years

Interventions/Control_2

Active treatment except all of DPP-4 inhibitors for 10 years

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

1) Type 2 diabetes
2) eGFR over 30ml/min/1.73m2
3) Diet end exercise are well performed
4) Understanding of the study procedures and consenting to it by signatures

Key exclusion criteria

1) Pregnant or being pregnant within the study
2) Contraindication with sitagliptin

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Sachiko
Middle name
Last name Hattori

Organization

Foundation Health Medicine Association Tohto Clinic

Division name

Department of Diabetes and Metabolism

Zip code

102-0094

Address

4-1 Kioi-Cho, Chiyoda-Ku, Tokyo, 102-0094, Japan

TEL

03-3239-0301

Email

s-hattori@kenkoigaku.or.jp


Public contact

Name of contact person

1st name Sachiko
Middle name
Last name Hattori

Organization

Foundation Health Medicine Association Tohto Clinic

Division name

Department of Diabetes and Metabolism

Zip code

102-0094

Address

4-1 Kioi-Cho, Chiyoda-Ku, Tokyo, 102-0094, Japan

TEL

03-3239-0301

Homepage URL


Email

s-hattori@kenkoigaku.or.jp


Sponsor or person

Institute

Department of Diabetes and Metabolism,Tohto Clinic

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

REC, Tohto Clinic

Address

4-1, Kioi-Cho, Chiyoda-Ku, Tokyo

Tel

03-3239-0301

Email

rinri-tohto @kenkoigaku.or.jp


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

2019 Year 11 Month 01 Day


Related information

URL releasing protocol

https://dmsjournal.biomedcentral.com/articles/10.1186/s13098-021-00735-3

Publication of results

Published


Result

URL related to results and publications

https://dmsjournal.biomedcentral.com/articles/10.1186/s13098-021-00735-3

Number of participants that the trial has enrolled

33

Results

The situation is equivalent to improving glycemic control as assessed by HbA1c both in a sitagliptin group (Sit-Gr) (n=17) or a control group (C-Gr) (n=9), while anti-inflammatory effects as assessed by hs-CRP in the Sit-Gr were superior to those in the C-Gr. In the Sit-Gr, ACR was markedly decreased, but no changes in eGFR were seen throughout the study. HOMA-beta was reduced at baseline in both groups, improved significantly in the Sit-Gr, and continued unchanged in the C-Gr during the study.

Results date posted

2021 Year 11 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

This single-center, open-label, randomized, prospective study included a total of 60 T2DM patients, 20-75 years old, with hemoglobin (Hb)A1c 8.0-6.5% and creatinine < 1.2 mg/dl regardless of diet, exercise, and medical treatment without a DPP4i for at least 12 months in this clinic. Patients with type 1 diabetes, unstable cardiac disease, history of cardiovascular disease (CVD), significant renal impairment (creatinine clearance < 30 ml/min), or elevated (more than twice the upper limit of normal) alanine aminotransferase, aspartate aminotransferase, or creatine phosphokinase were excluded. All patients continued medication with oral glucose-lowering drugs (sulfonylureas, metformin, or pioglitazone) that had already been administered. All other medications including antihypertensives (angiotensin II receptor blockers or calcium channel blockers) and antihyperlipidemic agents (statins or fibrates), remained unchanged during the study.

Participant flow

Patients were assigned at random to the sitagliptin group [sitagliptin (50 mg) as either monotherapy or combination therapy with other oral glucose-lowering drugs (n=30)] or the control group [placebo as either monotherapy or other glucose-lowering drugs other than DPP4i (n=22)]. Fasting blood and urine samples were collected before, and every 3 months after intervention for 10 years.

Adverse events

None.

Outcome measures

For all patients, blood and urine samples were collected after overnight fasting at baseline and then at intervals of three months for ten years. Assessments of high-sensitivity C-reactive protein (hsCRP), immunoreactive insulin (IRI), and urinary albumin were performed at LSI Medicine Corporation (Tokyo, Japan). Other biochemical data were generated in house. Homeostatic model assessment of insulin resistance (HOMA-IR) was calculated as (fasting blood glucose (FBG) * IRI)/405. Homeostatic model assessment of beta cell function (HOMA-beta) was calculated as (IRI * 360)/(fasting blood glucose (FBG) -63). Data on adverse experiences, physical examinations, vital signs, electrocardiograms, and body weight were collected on each visit.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2008 Year 10 Month 03 Day

Date of IRB

2019 Year 10 Month 08 Day

Anticipated trial start date

2008 Year 11 Month 01 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry

2021 Year 11 Month 06 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 01 Day

Last modified on

2021 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043558


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name