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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025235
Receipt No. R000029022
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.
Date of disclosure of the study information 2016/12/12
Last modified on 2018/03/12

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

Objectives
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

Assessment
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

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 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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Dokkyo Medical University
Organization
Division
Category of Funding Organization Other
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
2016 Year 12 Month 12 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
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
Other related information

Management information
Registered date
2016 Year 12 Month 12 Day
Last modified on
2018 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029022

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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