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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004953
Receipt No. 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

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

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
URL(English) https://upload.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


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