UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of the efficacy of INISYNC combination tablets and EquMet combination tablets LD on glycemic control in type 2 diabetic patients: A multicenter, open-label, randomized, parallel group, comparative trial.
Acronym	Comparison of the efficacy of INISYNC combination tablets and EquMet combination tablets LD on glycemic control in type 2 diabetic patients: A multicenter, open-label, randomized, parallel group, comparative trial.
Scientific Title	Comparison of the efficacy of INISYNC combination tablets and EquMet combination tablets LD on glycemic control in type 2 diabetic patients: A multicenter, open-label, randomized, parallel group, comparative trial.
Scientific Title:Acronym	Comparison of the efficacy of INISYNC combination tablets and EquMet combination tablets LD on glycemic control in type 2 diabetic patients: A multicenter, open-label, randomized, parallel group, comparative trial.
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 efficacy of alogliptin/metformin combination tablets and vildagliptin/metformin combination tablets on glycemic control in patients with type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes of HbA1c levels and fasting plasma glucose levels
Key secondary outcomes	1) Body weight, Waist circumference, Blood pressure 2) Fasting insulin and glucagon concentrations 3) Homeostasis model assessment-insulin resistance (HOMA-IR), Homeostasis model assessment of beta cell function (HOMA-beta), Serum lipids 4) Blood glucose area and blood glucose fluctuation index by flash glucose monitoring (FGM)

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Take alogliptin 25 mg/metformin 500 mg combination tablet once a day. Evaluate parameters before and after the 12 weeks treatment period.
Interventions/Control_2	Take vildagliptin 50 mg/metformin 250 mg combination tablet twice a day. Evaluate parameters before and after the 12 weeks treatment period.
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Outpatients 2) Type 2 diabetic patients who showed HbA1c levels 6.5 % to 10.0 % with anti-diabetic medications other than insulin therapy over 4 weeks before enrollment 3) Patients who showed written consent regarding participation in this study
Key exclusion criteria	1) Contraindications to alogliptin, vildagliptin, and metformin 2) Diabetic patients with type 1 diabetes and other causes 3) Diabetic ketoacidosis 4) Patients with a history of severe hypoglycemia with coma or loss of consciousness 5) Severe infection, severe trauma 6) Patients with poorly controlled hypertension despite drug treatment 7) Severe renal, hepatic and heart disease 8) Proliferative retinopathy 9) Patients with a history of malignant tumors 10) Not suitable for participate in this study from serious complications judged by a doctor 11) Women with the potential to become pregnant or pregnant, and lactating women 12) Patients judged by doctors to be inappropriate for participation in this study
Target sample size	65

Research contact person
Name of lead principal investigator	1st name Yasutaka Middle name Last name Takeda
Organization	Asahikawa Medical University
Division name	Division of Metabolism and Biosystemic Science, Department of Internal Medicine
Zip code	078-8510
Address	2-1-1-1 Midorigaoka Higashi, Asahikawa, Japan
TEL	0166-68-2454
Email	yktake5@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Yasutaka Middle name Last name Takeda
Organization	Asahikawa Medical University
Division name	Division of Metabolism and Biosystemic Science, Department of Internal Medicine
Zip code	078-8510
Address	2-1-1-1 Midorigaoka Higashi, Asahikawa, Japan
TEL	0166-68-2454
Homepage URL
Email	yktake5@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	Asahikawa Medical University
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	Asahikawa Medical University Research Ethics Committee
Address	2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido
Tel	0166-68-2187
Email	rs-kk.g@asahikawa-med.ac.jp

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	2018 Year 09 Month 01 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	61
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	2018 Year 06 Month 01 Day
Date of IRB	2018 Year 05 Month 31 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 23 Day
Last modified on	2021 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038627