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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033867
Receipt No. R000038627
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.
Date of disclosure of the study information 2018/09/01
Last modified on 2018/08/23

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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
Middle name
Last name Takeda Yasutaka
Organization Asahikawa Medical University
Division name Division of Metabolism and Biosystemic Science, Department of Internal Medicine
Zip code
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
Middle name
Last name Takeda Yasutaka
Organization Asahikawa Medical University
Division name Division of Metabolism and Biosystemic Science, Department of Internal Medicine
Zip code
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
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
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
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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 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
2018 Year 08 Month 23 Day
Last modified on
2018 Year 08 Month 23 Day


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

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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