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 |
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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
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
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
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
