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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018334
Receipt No. R000021219
Scientific Title Efficacy of trelagliptin for glucose fluctuation, oxidative stress and inflammation in patients with type 2 diabetes mellitus.
Date of disclosure of the study information 2015/07/17
Last modified on 2019/01/22

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Basic information
Public title Efficacy of trelagliptin for glucose fluctuation, oxidative stress and inflammation in patients with type 2 diabetes mellitus.
Acronym Efficacy of trelagliptin for glucose fluctuation, oxidative stress and inflammation in patients with type 2 diabetes mellitus.
Scientific Title Efficacy of trelagliptin for glucose fluctuation, oxidative stress and inflammation in patients with type 2 diabetes mellitus.
Scientific Title:Acronym Efficacy of trelagliptin for glucose fluctuation, oxidative stress and inflammation in patients with type 2 diabetes mellitus.
Region
Japan

Condition
Condition Patients with type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the effect of trelagliptin on glucose fluctuation, oxidative stress and inflammation in patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CGMS measurements (mean 24-h blood glucose level, fasting plasma glucose level, postprandial glucose level at 2 h after a meal, AUC, AOC, SD, MAGE)
Key secondary outcomes IL-6, IL-18, 8-OHdG, MDA-LDL, Hemoglobin A1C levels, BMI

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 Oral trelagliptin administration (100 mg) once a week after breakfast
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Outpatients
2) Inadequate glucose control even after dietary and exercise therapies for more than 8 weeks
3) 6.5% more than fasting HbA1c under 10%
4) Fasting blood glucose levels greater than 110mg/dl and under 250mg/dl
5) Patients who themselves can voluntarily provide consent to participate in this study, and can also follow the study protocol

Key exclusion criteria 1) Type 1 diabetes
2) Had ketosis or coma within 6 month
3) Secondary diabetes
4) Patients receiving insulin or GLP-1 analogue therapy
5) Poor-controlled diabetes (HbA1c>10.0 % or fasting blood glucose levels>250mg/dl)
6) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
7) Either level of aspartate aminotransaminase or alanine aminotransferase exceed three-fold of the normal limits
8) Renal insufficiency: serum creatinine>1.5 or Ccr<50ml/min
9) Malignancies or other diseases with poor prognosis
10) Pregnant
11) Subjects whose doctor in charge do not agree to join the trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Ida
Organization Ise Red Cross Hospital
Division name Department of Metabolic Diseases
Zip code
Address 471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL 0596-28-2171
Email bboy98762006@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Ida
Organization Ise Red Cross Hospital
Division name Department of Metabolic Diseases
Zip code
Address 471-2, Funae, 1-chome, Ise-shi, Mie, 516-8512
TEL 0596-28-2171
Homepage URL
Email bboy98762006@yahoo.co.jp

Sponsor
Institute Ise Red Cross Hospital
Department of Metabolic Diseases
Institute
Department

Funding Source
Organization Ise Red Cross Hospital
Department of Metabolic Diseases
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
2015 Year 07 Month 17 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 Terminated
Date of protocol fixation
2015 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 21 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 07 Month 16 Day
Last modified on
2019 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021219

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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