UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of glycemic variations in Japanese patients with type 2 diabetes, between metformin high dose group and combination of metformin and sitagliptin or linagliptin group as assessed by continuous glucose monitoring (CGM)
Title of the study (Brief title)	Comparison of glycemic variations in T2D, between metformin highdose group and combination of metformin and sitagliptin or linagliptin group as assessed by CGM
Region	Japan

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

Objectives
Narrative objectives1	To compare the glycemic variability by using CGM in patients with type 2 diabetes who receinig the metformin(1,500mg) versus receing the metformin(750mg) and sitagliptin(50mg) or linagliptin(5mg).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Glucose variability in CGM 1)Mean glucose levels 2)Standard deviations of glucose (SD) 3)MAGE 4)Time in hypoglycemia 5)Time in hyperglycemia 6)Area under the curve(AUC) 7)Magnitude of increase in glucose levels 8)The time to peak glucose levels from baseline after each meal
Key secondary outcomes	Pre-meal plasma glucose, 1 hour post prandial glucose, 2 hour post prandial glucose

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	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	After more than 4 weeks of treatment at metformin (1500mg), it change to sitagliptin (50mg) or linagliptin (5mg) + metformin (750mg).
Interventions/Control_2	After more than 4 weeks of treatment at sitagliptin (50mg) or linagliptin (5mg) + metformin (750mg), it change to metformin (1500mg).
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Type 2 diabetes 2)Patients who are administrated dose of metformin (500-1,000 mg/day) for 2 weeks or more 3)HbA1c >= 7.0% and <10.0% 4) Patients who were on the diet therapy 5)Patients who give written informed consent to participate in this study on a voluntary basis after receiving and understanding a sufficient explanation of the study
Key exclusion criteria	1)Patients with type 1 diabetes 2)Patients with insulin therapy 3)Patients who take oral hypoglycemic agent other than metformin 4)Patients with severe acidosis or diabetic coma 5)Patients with infections, before and after surgery,and severe trauma 6)Patiens with severe liver disease 7)Patients with severe renal disease with a serum creatinine (Cr) level (mg/dL) >1.5 8)Patients with shock, heart disease (heart failure, myocardial infarction, pulmonary embolism), severe lung failure 9)Patients with malnutrition, starvation, debilitating condition, pituitary dysfunction, adrenal insufficiency 10)Patients have history of lactic acidosis 11)Heavy drinkers 12)Patients with dehydration, gastrointestinal disorders (diarrhea, vomiting,etc) 13)Cancer patients 14)Patients for the biguanide drug with a history of allergy, or with a history of other drug allergy 15)Potential pregnant patients or patient with who are breast feeding
Target sample size	25

Research contact person
Name of lead principal investigator	Hiroshi Takahashi
Organization	Jikei University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Address	3-25-8, Nishishinbashi, Minato-ku, Tokyo, Japan
TEL	03-3433-1111
Email	hiro3431_6117@yahoo.co.jp

Public contact
Name of contact person	Hiroshi Takahashi
Organization	Jikei University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Address	3-25-8, Nishishinbashi, Minato-ku, Tokyo, Japan
TEL	03-3433-1111
Homepage URL
Email	hiro3431_6117@yahoo.co.jp

Sponsor
Institute	Jikei University School of Medicine
Institute
Department

Funding Source
Organization	Japan Diabetes Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
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 09 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 01 Day
Anticipated trial start date	2015 Year 09 Month 18 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2018 Year 03 Month 22 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 16 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021905