UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000013827
Receipt number	R000016138
Scientific Title	Efficacy of combination therapy of sitagliptin and low-dose glimepiride in patients with type 2 diabetes mellitus inadequately controlled with high-dose glimepiride
Date of disclosure of the study information	2014/04/30
Last modified on	2014/04/28 13:17:30

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Basic information

Public title

Efficacy of combination therapy of sitagliptin and low-dose glimepiride in patients with type 2 diabetes mellitus inadequately controlled with high-dose glimepiride

Acronym

Efficacy of combination therapy of sitagliptin and low-dose glimepiride

Scientific Title

Efficacy of combination therapy of sitagliptin and low-dose glimepiride in patients with type 2 diabetes mellitus inadequately controlled with high-dose glimepiride

Scientific Title:Acronym

Efficacy of combination therapy of sitagliptin and low-dose glimepiride

Region

Japan

Condition

type2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Evaluate the efficacy of low-dose glimepiride in combination therapy with sitagliptin.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Change of HbA1c

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Subjects with uncontrolled T2DM in high-dose(3-6mg) glimepiride were received reduced dose of glimepiride 0.5
mg/day,at the addition of 50 mg/day sitagliptin.We evaluated HbA1c at baseline and after 12 and 24 weeks.

Interventions/Control_2

Subjects with uncontrolled T2DM in high-dose(3-6mg) glimepiride were received reduced dose of glimepiride 1 mg/day,at the addition of 50 mg/day sitagliptin.We evaluated HbA1c at baseline and after 12 and 24 weeks.

Interventions/Control_3

Subjects with uncontrolled T2DM in high-dose(3-6mg) glimepiride were received reduced dose of glimepiride 2 mg/day,at the addition of 50 mg/day sitagliptin.We evaluated HbA1c at baseline and after 12 and 24 weeks.

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

Eligible subjects were treated with glimepiride at dose of 3-6mg/day (with or without Metformin,alpha-glucosidase inhibitor, and Thiazolidinedione) for at least 3 months and HbA1c level > =6.9%.

Key exclusion criteria

Subjects with type 1 diabetes mellitus, secondary diabetes, diabetic nephropathy stage 4-5, malignancy or other severe conditions, aged < 20, were excluded.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Tatsuhide Inoue

Organization

Shizuoka General Hospital

Division name

Center for Endocrinology and Metabolism

Zip code

Address

4-27-1,Kita-Ando,Aoi-ku,Shizuoka,Japan

TEL

054-247-6111

Email

tatsuhide-inoue@i.shizuoka-pho.jp

Public contact

Name of contact person

1st name

Middle name

Last name Rieko Umayahara

Organization

Shizuoka General Hospital

Division name

Center for Endocrinology and Metabolism

Zip code

Address

4-27-1,Kita-Ando,Aoi-ku,Shizuoka,Japan

TEL

054-247-6111

Homepage URL

Email

fwkh7040spring@yahoo.co.jp

Sponsor or person

Institute

Shizuoka General Hospital

Institute

Department

Personal name

Funding Source

Organization

Joint Reseach Association for Japanese Diabetes

Organization

Division

Category of Funding Organization

Other

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 30 Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Despite dose reducion of glimepiride, combination therapy with sitagliptin induced significant improvement of HbA1c level (-0.9 %, P < 0.001) at 24 weeks.Among the three groups, there were no meaningful differences in changes from baseline in HbA1c.(The 56th Annual meeting of the Japan Diabetes Society)

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

Completed

Date of protocol fixation

2011 Year 01 Month 18 Day

Date of IRB

Anticipated trial start date

2011 Year 01 Month 25 Day

Last follow-up date

2011 Year 12 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2014 Year 04 Month 28 Day

Last modified on

2014 Year 04 Month 28 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016138

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name