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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010645
Receipt No. R000012449
Scientific Title Active GLP-1 as prediction Factor of Effect of Sitagliptin on patients with Type 2 diabetes mellitus
Date of disclosure of the study information 2013/05/03
Last modified on 2016/07/06

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Basic information
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
Condition Type 2 Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes HbA1c
Key secondary outcomes PI/IRI, glucagon, insulin, active GLP-1

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute The Institute for Adult Diseases, Asahi Life Foundation
Institute
Department

Funding Source
Organization The Institute for Adult Diseases, Asahi Life Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 05 Month 03 Day

Related information
URL releasing protocol http://www.wjgnet.com/1948-9358/full/v7/i11/230.htm
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2013 Year 05 Month 03 Day
Last modified on
2016 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012449

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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