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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015033
Receipt No. R000017489
Scientific Title Comparison of DPP-4 Inhibitors versus Dapagliflozin in combination with insulin using continuous glucose monitoring in patients with type 2 diabetes mellitus -prospective randomized controlled trial-
Date of disclosure of the study information 2014/09/03
Last modified on 2017/09/04

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Basic information
Public title Comparison of DPP-4 Inhibitors versus Dapagliflozin in combination with insulin using continuous glucose monitoring in patients with type 2 diabetes mellitus -prospective randomized controlled trial-
Acronym Comparison of DPP-4 Inhibitors vs. Dapagliflozin in combination with insulin using CGM
Scientific Title Comparison of DPP-4 Inhibitors versus Dapagliflozin in combination with insulin using continuous glucose monitoring in patients with type 2 diabetes mellitus -prospective randomized controlled trial-
Scientific Title:Acronym Comparison of DPP-4 Inhibitors vs. Dapagliflozin in combination with insulin using CGM
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of DPP-4 Inhibitors and Dapagliflozin using CGM in patients with type 2 diabetes treating with insulin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Mean Amplitude of glycemic excursions: MAGE
Key secondary outcomes 1) M-value 2) glucose area under the curve (over 180mg/dl and below 70mg/dl) 3) fasting plasma glucose, HbA1c, glycoalbumin, 1.5AG 4) beta cell function 5) several biomarkers 6) body weight, Body Mass Index 7) blood pressure 8)multiple regression analysis 9)insulin dose

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Sitagliptin
Vildagliptin
Teneligliptin
Linagliptin
Alogliptin
Saxagliptin
Interventions/Control_2 Dapagliflozin
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) patients with type 2 diabetes treating in combination with Inslin and DPP-4 inhibitors 2) HbA1c 6.0-9.0% 3) written informed consent
Key exclusion criteria 1) severe hepatic dysfunction, renal dysfunction, heart failure, 2) history of anaphylaxis of drugs we use, 3) pregnancy, 4) lower than 45ml/min of eGFR, 5)lower Body mass index than 22kg/m2 6) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Miyoshi
Organization Hokkaido University Hospital
Division name Department of Internal Medicine II
Zip code
Address Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5915
Email hidemiyoshi2003@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Miyoshi
Organization Hokkaido University Hospital
Division name Department of Internal Medicine II
Zip code
Address Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5915
Homepage URL
Email hidemiyoshi2003@yahoo.co.jp

Sponsor
Institute Hokkaido University Hospital
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

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 03 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://dmsjournal.biomedcentral.com/articles/10.1186/s13098-017-0255-8
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
2014 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 07 Day
Last follow-up date
2017 Year 02 Month 28 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 09 Month 02 Day
Last modified on
2017 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017489

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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