UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of trelagliptin for glucose fluctuation, oxidative stress and inflammation in patients with type 2 diabetes mellitus.
Title of the study (Brief title)	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	Satoshi Ida
Organization	Ise Red Cross Hospital
Division name	Department of Metabolic Diseases
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	Satoshi Ida
Organization	Ise Red Cross Hospital
Division name	Department of Metabolic Diseases
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 07 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021219