UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028988
Receipt number R000033168
Scientific Title Which is the most compatible combination of oral hypoglycemic agents that incretin action are considered used together with basal insulin? Comparison of Vildagliptin 100 mg +Metformin 500 mg vs. Vildagliptin 100 mg +Miglitol 150 mg vs. Metformin 500 mg+Miglitol 150 mg using FreeStyle Libre Pro: randomised triple crossover study
Date of disclosure of the study information 2017/09/04
Last modified on 2018/05/08 10:54:02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Which is the most compatible combination of oral hypoglycemic agents that incretin action are considered used together with basal insulin? Comparison of Vildagliptin 100 mg +Metformin 500 mg vs. Vildagliptin 100 mg +Miglitol 150 mg vs. Metformin 500 mg+Miglitol 150 mg using FreeStyle Libre Pro: randomised triple crossover study

Acronym

Comparison of Vildagliptin 100 mg +Metformin 500 mg vs. Vildagliptin 100 mg +Miglitol 150 mg vs. Metformin 500 mg+Miglitol 150 mg using FreeStyle Libre Pro: randomised triple crossover study

Scientific Title

Which is the most compatible combination of oral hypoglycemic agents that incretin action are considered used together with basal insulin? Comparison of Vildagliptin 100 mg +Metformin 500 mg vs. Vildagliptin 100 mg +Miglitol 150 mg vs. Metformin 500 mg+Miglitol 150 mg using FreeStyle Libre Pro: randomised triple crossover study

Scientific Title:Acronym

Comparison of Vildagliptin 100 mg +Metformin 500 mg vs. Vildagliptin 100 mg +Miglitol 150 mg vs. Metformin 500 mg+Miglitol 150 mg using FreeStyle Libre Pro: randomised triple crossover study

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate which is the most compatible combination of oral hypoglycemic agents that incretin action are considered used together with basal insulin, Vildagliptin 100 mg +Metformin 500 mg, Vildagliptin 100 mg +Miglitol 150 mg or Metformin 500 mg+Miglitol 150 mg.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

24h glycemic variability percentage (GVP)

Key secondary outcomes

24h percentage of time in target range (70~140 mg/dL)
24h mean absolute glucose (MAG)
mean glucose level (24h, 00:00~06:00, 08:00~24:00)
standard deviation (SD)(24h, 00:00~06:00, 08:00~24:00)
coefficient of variation (CV)(24h, 00:00~06:00, 08:00~24:00)
MAGE
MODD
ADRR
HIgh blood glucose index (HBGI)
Highest postprandial glucose level within 3 hours after each meal
AOC (<70 mg/dL) for glycemic variability (24h)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

FreeStyle Libre Pro is worn after admission. Vildagliptin 100 mg +Metformin 500 mg are evaluated on day 3 and day 4. Then, Vildagliptin 100 mg +Miglitol 150 mg are evaluated on day 8 and day 9. Then, Metformin 500 mg+Miglitol 150 mg are evaluated on day 13 and day 14.

Interventions/Control_2

FreeStyle Libre Pro is worn after admission. Metformin 500 mg+Miglitol 150 mg are evaluated on day 3 and day 4. Then, Vildagliptin 100 mg +Metformin 500 mg are evaluated on day 8 and day 9. Then, Vildagliptin 100 mg +Miglitol 150 mg are evaluated on day 13 and day 14.

Interventions/Control_3

FreeStyle Libre Pro is worn after admission. Vildagliptin 100 mg +Miglitol 150 mg are evaluated on day 3 and day 4. Then, Metformin 500 mg+Miglitol 150 mg are evaluated on day 8 and day 9. Then, Vildagliptin 100 mg +Metformin 500 mg are evaluated on day 13 and day 14.

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 diabetic patients medicated with insulin glargine 300 U/ml for 3 month or longer

Key exclusion criteria

severe renal dysfunction (eGFR less than 45)
judged to be unsuitable for participation for medical reasons

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Soichi Takeishi

Organization

General Inuyama Chuo Hospital

Division name

Department of Diabetes

Zip code


Address

6, Futagozuka, Goromaru, Inuyama-city, Aichi, 484-8511, 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

General Inuyama Chuo Hospital

Division name

Department of Diabetes

Zip code


Address

6, Futagozuka, Goromaru, Inuyama-city, Aichi, 484-8511, Japan.

TEL

0568-62-8111

Homepage URL


Email

souichi19811225@yahoo.co.jp


Sponsor or person

Institute

General Inuyama Chuo Hospital

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

2017 Year 09 Month 04 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

2017 Year 09 Month 04 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 04 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

2017 Year 09 Month 04 Day

Last modified on

2018 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033168


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name