UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033867
Receipt number 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 2021/08/25 10:18:56

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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 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 or person

Institute

Asahikawa Medical University

Institute

Department

Personal name



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

Value
https://center6.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