UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019833
Receipt number R000022728
Scientific Title Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy
Date of disclosure of the study information 2015/11/18
Last modified on 2017/05/22 08:49:13

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Basic information

Public title

Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy

Acronym

Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy

Scientific Title

Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin therapy

Scientific Title:Acronym

Effectiveness of mitiglinide and mitiglinide/voglibose combination tablets during insulin step-down after intensive insulin 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 investigate the background characteristics of type 2 diabetes mellitus patients that provide an advantage to switch the additional insulin of intensive insulin therapy after the resolution of glucose toxicity to mitiglinide calcium hydrate tablets or mitiglinide calcium hydrate/voglibose combination tablets. The efficacy of mitiglinide calcium hydrate tablets as well as mitiglinide calcium hydrate/voglibose combination tablets on basal insulin use is also studied.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1) Mean amplitude of glycemic excursions (MAGE)
2) Mean blood glucose level
3) Standard deviation (SD) of blood glucose level
4) Rate of glucose level AUC>=180 mg/dL, 70 mg/dL<AUC<180 mg/dL, and <70 mg/dL
5) Maximum and minimum blood glucose levels
6) Incidence of symptomatic hypoglycemia
7) Rate of glucose level <70 mg/dL
8) Blood glucose levels 1 and 2 h after every meal
9) Age, duration of diabetes, urinary CPR, 75g oral glucose tolerance test results (blood glucose, blood insulin, and blood CPR levels before the load, and 30 min, 1 hour and 2 hours after the load), glucagon stimulation test results (blood glucose, blood insulin, and blood CPR levels before and after the load), and the daily dose of additional insulin, the daily dose of basal insulin and the daily dose of total insulin at the time of informed consent

Key secondary outcomes



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

After receiving mitiglinide for two days, patients receive mitiglinide / voglibose combination tablets for two days.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Type 2 diabetes mellitus patients who are receiving intensive insulin therapy
2) Age >=20 years at the time of obtaining consent
3) Hospitalized patients
4) Patients whose glucose toxicity had resolved as judged by the investigator or sub-investigator (e.g., blood glucose level <150 mg/dL at 4 time points throughout a day; namely, before breakfast, before lunch, before dinner, and before going to bed)
5) Patients who are receiving <20 units/day of additional insulin
6) Patients who provided written consent

Key exclusion criteria

1) Patients who are taking other antidiabetes agents than insulin
2) Patients with contraindications against the use of mitiglinide calcium hydrate tablets and mitiglinide calcium hydrate/voglibose combination tablets based on their package inserts
3) Patients who were judged to be ineligible by the investigator or sub-investigator

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jiro Nakamura

Organization

Aichi Medical University

Division name

Division of Diabetes

Zip code


Address

1-1 Yazakokarimata Nagakute-shi Aichi-ken

TEL

0561-63-1683

Email

jiro@aichi-med-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Kamiya

Organization

Aichi Medical University

Division name

Division of Diabetes

Zip code


Address

1-1 Yazakokarimata Nagakute-shi Aichi-ken

TEL

0561-63-1683

Homepage URL


Email

hkamiya@aichi-med-u.ac.jp


Sponsor or person

Institute

Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kissei Pharmaceutical Co.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

愛知医科大学病院 Aichi Medical University Hospital


Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 18 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

2015 Year 05 Month 26 Day

Date of IRB


Anticipated trial start date

2015 Year 12 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

2015 Year 11 Month 18 Day

Last modified on

2017 Year 05 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022728


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name