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
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
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
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
