UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004953
Receipt number R000005896
Scientific Title A randomized open study to compare the efficacy and safety of GLP-1 analogue (Liraglutide) versus DPP-4 inhibitor (Vildagliptin) in patients with Type 2 Diabetes.
Date of disclosure of the study information 2011/02/01
Last modified on 2012/05/25 14:49:21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A randomized open study to compare the efficacy and safety of GLP-1 analogue (Liraglutide) versus DPP-4 inhibitor (Vildagliptin) in patients with Type 2 Diabetes.

Acronym

ERA-DM Chapter 2

Scientific Title

A randomized open study to compare the efficacy and safety of GLP-1 analogue (Liraglutide) versus DPP-4 inhibitor (Vildagliptin) in patients with Type 2 Diabetes.

Scientific Title:Acronym

ERA-DM Chapter 2

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To compare the efficacy and safety of GLP-1 analogue (Liraglutide) versus DPP-4 inhibitor (Vildagliptin) on metabolic parameters and Body composition in people with type 2 diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

HbA1c,Body weight

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

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

Vildagliptin

Interventions/Control_2

Liraglutide

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

1)Type 2 diabetes
2)HbA1c >=6.5% during 8 weeks prior to the study
3)Treated with Sitaglptin only or Sitagliptin and single oral hypoglycemic agent(OHA:SU,BG,TZD) over 12 weeks prior to the study

Key exclusion criteria

1)Hypersensitivity to or contraindication of Liraglutide and Vildagliptin
2)None Type 2 diabetes
3)Medical history and/or complication of Diabetic ketoacidosis
4)Medical history and/or complication of severe hypoglycemia
5)Insulin treatment within 4 weeks prior to the study
6)Treatment with Liraglutide or Vildagliptin within 12 weeks prior to the study
7)New or Change treatment with Glucocorticoid
8)Unstable glycemic contol
9)Ccr(Cockcraft) < 30mL/h or
sCre > 2.5 mg/dL(male), > 2.0mg/dL (Female)
10)AST or ALT >=2.5 time of institutional upper normal limit
11)Uncontrolled hypertension(systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
12)Severe health problems not suitable for the study
13)Pregnant or lactating women

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name TAKAMURA Toshinari

Organization

Kanazawa University Graduate School of Medical Science

Division name

Department of Disease Control and Homeostasis

Zip code


Address

13-1 Takara-machi, Kanazawa, Ishikawa, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kanazawa University Graduate School of Medical Science

Division name

Department of Disease Control and Homeostasis

Zip code


Address

13-1 Takara-machi, Kanazawa, Ishikawa, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Science

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


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

市立敦賀病院(福井県)、もりやま越野病院(石川県)、半田内科医院(石川県)、石田病院(石川県)、加登病院(石川県)、富山県立中央病院(富山県)、富山市民病院(富山県)、市立砺波総合病院(富山県)、能登総合病院(石川県)、金沢医療センター(石川県)、金沢市立病院(石川県)、金沢赤十字病院(石川県)、 公立松任石川中央病院(石川県)、河北中央病院(石川県)、公立羽咋病院(石川県)、福井済生会病院(福井県)、T’sクリニック(石川県)


Other administrative information

Date of disclosure of the study information

2011 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

No longer recruiting

Date of protocol fixation

2010 Year 12 Month 09 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 01 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

2011 Year 01 Month 25 Day

Last modified on

2012 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005896


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name