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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023245
Receipt No. R000026787
Scientific Title Efficacy and safety of dulaglutide when used instead of sitagliptin in type 2 diabetic patients
Date of disclosure of the study information 2016/07/25
Last modified on 2017/04/12

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Basic information
Public title Efficacy and safety of dulaglutide when used instead of sitagliptin in type 2 diabetic patients
Acronym Efficacy and safety of dulaglutide when used instead of sitagliptin in type 2 diabetic patients
Scientific Title Efficacy and safety of dulaglutide when used instead of sitagliptin in type 2 diabetic patients
Scientific Title:Acronym Efficacy and safety of dulaglutide when used instead of sitagliptin in type 2 diabetic patients
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare efficacy and safety of dulaglutide in type 2 diabetes mellitus patients who are formerly treated with sitagliptin
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Change of HbA1c,body weight at the 12th and the 24th week.
Key secondary outcomes Change of data shown below at the 12th and the 24th week.

AST, ALT, gamma-GTP, LDL-C, HDL-C,TG, non-HOL-C, serum creatinine, serum UA

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 The patients are treated with dulaglutide instead of sitagliptin from the start to the 24th week.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Type 2 diabetes with HbA1c =/> 6.5%
Key exclusion criteria 1. Type 1 diabetes
2. Patients with severe renal failure or liver dysfunction
3. Patients with drug allergy for ipraglifrozin
4. Patients with history of diabetec ketosis
5. Patients with shick day
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Iwasaki
Organization Iwasaki Naika Clinic
Division name Endocrinology and Metabolism
Zip code
Address 1-1-5-1F Kamihoshikawa, Hodogayaku, Yokohama, Kanagawa, Japan
TEL 045-442-6475
Email iwasaki11111@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Iwasaki
Organization Iwasaki Naika Clinic
Division name Endocrinology and Metabolism
Zip code
Address 1-1-5-1F Kamihoshikawa, Hodogayaku, Yokohama, Kanagawa, Japan
TEL 045-442-6475
Homepage URL
Email iwasaki11111@gmail.com

Sponsor
Institute Iwasaki Naika Clinic
Institute
Department

Funding Source
Organization Iwasaki Naika Clinic
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 岩崎内科クリニック

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 25 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 Completed
Date of protocol fixation
2016 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 25 Day
Last follow-up date
2017 Year 04 Month 28 Day
Date of closure to data entry
2017 Year 04 Month 28 Day
Date trial data considered complete
2017 Year 04 Month 28 Day
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 20 Day
Last modified on
2017 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026787

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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