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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034426
Receipt No. R000039259
Scientific Title Comparison of voglibose and pioglitazone in basal insulin with multiple oral hypoglycemic agents therapy using continuous glucose monitoring
Date of disclosure of the study information 2018/10/09
Last modified on 2019/01/31

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Basic information
Public title Comparison of voglibose and pioglitazone in basal insulin with multiple oral hypoglycemic agents therapy using continuous glucose monitoring
Acronym Comparison of voglibose and pioglitazone in basal insulin with multiple oral hypoglycemic agents therapy
Scientific Title Comparison of voglibose and pioglitazone in basal insulin with multiple oral hypoglycemic agents therapy using continuous glucose monitoring
Scientific Title:Acronym Comparison of voglibose and pioglitazone in basal insulin with multiple oral hypoglycemic agents therapy
Region
Japan

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

Objectives
Narrative objectives1 To compare between glycemic variability of patients in whom voglibose is added to metformin, vildagliptin, tofoglifrozin, and insulin glargine 300 U/ml (glargine 300) and glycemic variability of patients in whom pioglitazone is added to those.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 24-h Percentage of time in target range (70~180 mg/dL)
Key secondary outcomes 24-h Mean absolute glucose (MAG)
24-h Glycemic variability percentage (GVP)
Mean glucose level (24:00, 0:00-6:00, 8:00-24:00)
Standard deviation (SD) (24:00, 0:00-6:00, 8:00-24:00)
Coefficient of variation (CV) (24:00, 0:00-6:00, 8:00-24:00)
High blood glucose index (HBGI)
low blood glucose index (LBGI)
Percentage of time in range (<70 mg/dL)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 40 outpatients with type 2 diabetes treated with metformin 1000mg, vildagliptin 100mg, tofoglifrozin 20mg, and glargine 300 for 3 month or longer are randomly allocated into 2 groups.
Group 1: Voglibose is added to outpatients who agree to participate this study; next, glargine 300 injected at 8 am are titrated with an algorithm for 2 weeks; the dose of glargine 300 is then maintained for 2 week and fasting glcose levels are stabilized. (final registration criteria)
1 month after voglibose or pioglitazone are added, during hospitalization, patients wear a continuous glucose monitoring device (iPro2) and glycemic variability is evaluated on day3.
Interventions/Control_2 40 outpatients with type 2 diabetes treated with metformin 1000mg, vildagliptin 100mg, tofoglifrozin 20mg, and glargine 300 for 3 month or longer are randomly allocated into 2 groups.
Group 2:
Pioglitazone is added to outpatients who agree to participate this study; next, glargine 300 injected at 8 am are titrated with an algorithm for 2 weeks; the dose of glargine 300 is then maintained for 2 week and fasting glcose levels are stabilized. (final registration criteria)
1 month after voglibose or pioglitazone are added, during hospitalization, patients wear a continuous glucose monitoring device (iPro2) and glycemic variability is evaluated on day3.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria type 2 diabetes treated with metformin 1000mg, vildagliptin 100mg, tofoglifrozin 20mg, and insulin glargine 300 U/ml for 3 month or longer
Key exclusion criteria patients who cannot achive the final registration criteria.
severe renal dysfunction (eGFR less than 45)
judged to be unsuitable for participation for medical reasons
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soichi Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
Zip code
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL 0568-62-8111
Email souichi19811225@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Soichi Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
Zip code
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL 0568-62-8111
Homepage URL
Email souichi19811225@yahoo.co.jp

Sponsor
Institute Inuyama Chuo General Hospital
Institute
Department

Funding Source
Organization Inuyama Chuo General Hospital
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
2018 Year 10 Month 09 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 11 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
2018 Year 10 Month 09 Day
Last modified on
2019 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039259

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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