UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034426
Receipt number 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 2022/11/18 09:15:01

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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 Soichi
Middle name
Last name Takeishi

Organization

Inuyama Chuo General Hospital

Division name

Diabetes

Zip code

484-8511

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 Soichi
Middle name
Last name Takeishi

Organization

Inuyama Chuo General Hospital

Division name

Diabetes

Zip code

484-8511

Address

6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.

TEL

0568-62-8111

Homepage URL


Email

souichi19811225@yahoo.co.jp


Sponsor or person

Institute

Inuyama Chuo General Hospital

Institute

Department

Personal name



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

Inuyama Chuo General Hospital

Address

6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.

Tel

0568-62-8111

Email

souichi19811225@yahoo.co.jp


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

36

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

2018 Year 10 Month 05 Day

Date of IRB

2018 Year 10 Month 27 Day

Anticipated trial start date

2018 Year 11 Month 01 Day

Last follow-up date

2019 Year 12 Month 31 Day

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

2022 Year 11 Month 18 Day



Link to view the page

Value
https://center6.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