UMIN-CTR Clinical Trial

Public title

The Clinical Comparison of Antidiabetic Agents Treating Postprandial Hyperglycemia, between Repaglinide alone and Mitiglide/Voglibose Fixed-dose Combination using Continuous Glucose Monitoring on Postprandial Profiles.

Acronym

The comparison between glinides and glinides/aGI combination therapy using CGM

Scientific Title

The Clinical Comparison of Antidiabetic Agents Treating Postprandial Hyperglycemia, between Repaglinide alone and Mitiglide/Voglibose Fixed-dose Combination using Continuous Glucose Monitoring on Postprandial Profiles.

Scientific Title:Acronym

The comparison between glinides and glinides/aGI combination therapy using CGM

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

After admission,all patients had post prandial hyperglycemia.
glycemic levels were monitored for7 consecutive days using CGM (ipro2; Medtronic MiniMedInc., Northridge, CA).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Total area under the curve (AUC) within 2 h after each meal, and postprandial glucose levels within 2 h after each meals using
24-h glycemic data from CGM

Key secondary outcomes

we evaluated 24-h mean glucose levels,the mean of the daily difference, mean amplitude of glycemic excursions,rates of proportions of appropriate glucose levels, hyperglycemia, andhypoglycemia

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Glycemic levels were monitored for 7 consecutive days using CGM (ipro2; Medtronic MiniMed
Inc., Northridge, CA).During the study period, the dose ofinsulin and other antidiabetic drugs were fixed.The patients were divided three arms.
After starting glucose monitoring,
1) The patients took repaglinide 0.5g three times daily immediately before each meals for two consecutive days, after that miti10mg/Vog0.2mg three times before each meal for two days,the last two days, kept conventional treatment.

Interventions/Control_2

After starting glucose monitoring,
2) The patients kept conventional treatment for two days, after that took repaglinide 0.5mg three times daily immediately before each meals for two consecutive days,the last two days, took miti10mg/Vog0.2mg three times daily immediately before each meals.

Interventions/Control_3

After starting glucose monitoring,
3) The patients took miti10mg/Vog0.2mg three times daily immediately before each meals.kept conventional treatment for two consecutive days, after that, kept conventional treatment for two days,the last two days, took repaglinide 0.5mg three times daily immediately before each meals.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Type 2 diabetes in patient
2)Postprandial glucose levels > 180mg/dl
3)HbA1c values at admition between 7.0 and 13.5%
4)Patients who gave written informed consent

Key exclusion criteria

1)Patients who have severe diabeticketosis, diabetic coma
2)Patients with severe infections, severe injury or perioperative state.
3)Female patients who have pregnancy or possibilty of pregnancy, or are under lactation
4)Patients who had past history of hypersensitivity or allergic reaction to insulin degludec, aspart or liraglutide
5)Patients with severe liver or renal dysfunction.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Yoshimasa Aso

Organization

Dokkyo Medical University

Division name

Endocrinology and Metabolism

Zip code

Address

880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan

TEL

0282-86-1111

Email

yaso@dokkyomed.ac.jp

Name of contact person

1st name
Middle name
Last name	Takafumi Niitani

Organization

Dokkyo Medical University

Division name

Endocrinology and Metabolism

Zip code

Address

880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan

TEL

0282-86-1111

Homepage URL

Email

niinii@dokkyomed.ac.jp

Institute

Dokkyo Medical University

Institute

Department

Personal name

Organization

Dokkyo Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

12

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

11

Month

29

Day

Date of IRB

Anticipated trial start date

2016

Year

12

Month

06

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

12

Month

12

Day

Last modified on

2018

Year

03

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029022