UMIN-CTR Clinical Trial

Public title

Active GLP-1 as prediction Factor of Effect of Sitagliptin on patients with Type 2 diabetes mellitus

Acronym

A GLP-1 FEST

Scientific Title

Active GLP-1 as prediction Factor of Effect of Sitagliptin on patients with Type 2 diabetes mellitus

Scientific Title:Acronym

A GLP-1 FEST

Region

Japan

Condition

Type 2 Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the predictive value of active GLP-1 for glucose lowering effect on patients with type 2 diabetes mellitus

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

HbA1c

Key secondary outcomes

PI/IRI, glucagon, insulin, active GLP-1

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

Sitagliptin 50mg

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

Patients with type 2 diabetes
Age>=20 years old
HbA1c >= 6.9%
Agreeing to participate the investigation

Key exclusion criteria

Previously taking DPP-IV inhibitor or GLP-1 mimetics

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Akifumi Kushiyama

Organization

The Institute for Adult Diseases, Asahi Life Foundation

Division name

Diabetes and Metabolism

Zip code

Address

2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo, Japan

TEL

03-3639-5501

Email

kusiyaa-tky@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Kushiyama Akifumi

Organization

The Institute for Adult Diseases, Asahi Life Foundation

Division name

Diabetes and Metabolism

Zip code

Address

2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo, Japan

TEL

03-3639-5501

Homepage URL

http://www.asahi-life.or.jp

Email

kusiyaa-tky@umin.ac.jp

Institute

The Institute for Adult Diseases, Asahi Life Foundation

Institute

Department

Personal name

Organization

The Institute for Adult Diseases, Asahi Life Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

05

Month

03

Day

URL releasing protocol

http://www.wjgnet.com/1948-9358/full/v7/i11/230.htm

Publication of results

Published

URL related to results and publications

http://www.wjgnet.com/1948-9358/full/v7/i11/230.htm

Number of participants that the trial has enrolled

Results

AIM: To investigate whether active glucagon-like peptide-1 (GLP-1) is a prediction Factor of Effect of sitagliptin on patients with type 2 diabetes mellitus (GLP-1 FEST:UMIN000010645).

METHODS: Seventy-six patients with type 2 diabetes, who had insufficient glycemic control [Hemoglobin A1c (HbA1c) >= 7%] in spite of treatment with metformin and/or sulfonylurea, were included in the investigation. Patients were divided into three groups by tertiles of fasting plasma active GLP-1 level, before the administration of 50 mg sitagliptin.

RESULTS: At baseline, body mass index, serum UA, insulin and HOMA-IR were higher in the high active GLP-1 group than in the other two groups. The high active GLP-1 group did not show any decline of HbA1c (7.6% +- 1.4% to 7.5% +- 1.5%), whereas the middle and low groups indicated significant decline of HbA1c (7.4 +- 0.7 to 6.8 +- 0.6 and 7.4 +- 1.2 to 6.9 +- 1.3, respectively) during six months. Only the low and middle groups showed a significant increment of active GLP-1, C-peptide level, a decreased log and proinsulin/insulin ratio after administration. In logistic analysis, the low or middle group is a significant explanatory variable for an HbA1c decrease of >= 0.5%, and its odds ratio is 4.5 (1.40-17.6) (P = 0.01) against the high active GLP-1 group. This remains independent when adjusted for HbA1c level before administration, patients' medical history, medications, insulin secretion and insulin resistance.

CONCLUSION: Plasma fasting active GLP-1 is an independent predictive marker for the efficacy of dipeptidyl peptidase 4 inhibitor sitagliptin.

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

Main results already published

Date of protocol fixation

2011

Year

03

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

03

Month

11

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

05

Month

03

Day

Last modified on

2016

Year

07

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012449