UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047481 |
|---|---|
| Receipt number | R000054143 |
| Scientific Title | Comparison of clinical efficacy between SGLT2 inhibitors and biguanides as additional treatment for patients with type 2 diabetes treated with DPP-4 inhibitors: a retrospective comparative study |
| Date of disclosure of the study information | 2022/04/14 |
| Last modified on | 2024/02/28 10:52:13 |
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Basic information
Public title
A retrospective comparative study of the clinical efficacy of SGLT2 inhibitors and biguanides as additional treatment for patients with type 2 diabetes treated with DPP-4 inhibitors
Acronym
ADDED study
Scientific Title
Comparison of clinical efficacy between SGLT2 inhibitors and biguanides as additional treatment for patients with type 2 diabetes treated with DPP-4 inhibitors: a retrospective comparative study
Scientific Title:Acronym
ADDED study
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the comparison of the clinical effects of adding SGLT2 inhibitors or biguanides in type 2 diabetic patients who are treated with PP-4 inhibitors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference in glucose metabolism marker, such as fasting plasma glucose and HbA1c between the addition of SGLT2 inhibitors and the addition of biguanides will be evaluated after 1, 3 and 6 months.
Key secondary outcomes
1: Comparing the difference in body weight and/or BMI between the addition of SGLT2 inhibitors and the addition of biguanides will be evaluated after 1, 3 and 6 months.
2: Comparing the difference in several factors as follow between the addition of SGLT2 inhibitors and the addition of biguanides will be evaluated after 1, 3 and 6 months.
1.Ht
2.systolic blood pressure (mmHg)
3.diastolic blood pressure (mmHg)
4.lipid profile
5.renal function: eGFR (ml/min/1.73m2)
6.liver function: AST, ALT, GGT
7.FIB-4 index
8.UA
3: Association the change of HbA1c and several factors as follow between two groups.
1.Ht
2.systolic blood pressure (mmHg)
3.diastolic blood pressure (mmHg)
4.lipid profile
5.renal function: eGFR (ml/min/1.73m2)
6.liver function: AST, ALT, GGT
7.FIB-4 index
8.UA
9.body weight (kg), BMI (kg/mm2)
10.detail of medication and number of take medicine
11.detail of the diabetic macro- or micro-vascular complication and number of complications.
4: Association the change of body weight and several factors as follow between two groups.
1.Ht
2.FPG (mg/dL)
3.HbA1c
4.systolic blood pressure (mmHg)
5.diastolic blood pressure (mmHg)
6.lipid profile
7.renal function: eGFR (ml/min/1.73m2)
8.liver function: AST, ALT, GGT
9.FIB-4 index
10.UA
11.detail of medication and number of take medicine
12.detail of the diabetic macro- or micro-vascular complication and number of complications.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The selection criteria for the subjects are as follow.
1. Patients who have been diagnosed as type 2 diabetes.
2. Over 20 years old.
Key exclusion criteria
The exclusion criteria for the subjects are as follow.
1. Subjects with acute and/or chronic inflammation
2. Subjects with fresh cardiovascular and/or cerebrovascular diseases
3. Subjects with liver cirrhosis.
4. Subjects with severe respiratory disease or severe heart failure
5. Subjects with alcoholicsm or medicinal intoxication
6. Subjects with psychosis
7. Subjects who doctors judge as unfitness
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Matsumura |
Organization
Nishinihon hospital
Division name
Metabolic Medicine
Zip code
861-8034
Address
3-20-1 hattanda, higasi, Kumamoto, Kumamoto
TEL
096-380-1111
takeshim@gpo.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Matsumura |
Organization
Nishinihon Hospital
Division name
Metabolic Medicine
Zip code
861-8034
Address
3-20-1 hattanda, higasi, Kumamoto, Kumamoto
TEL
096-380-1111
Homepage URL
takeshim@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Metabolic Medicine, Nishinihon Hospital
Institute
Department
Personal name
Takeshi Matsumura
Funding Source
Organization
Nishinihon Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nishinihon Hospital Ethics Review Committee
Address
3-20-1 hattanda, higasi, Kumamoto, Kumamoto
Tel
096-380-1111
takeshim@gpo.kumamoto-u.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
| 2022 | Year | 04 | Month | 14 | 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
372
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Assessment
The difference in glucose metabolism marker, such as fasting plasma glucose and HbA1c between the addition of SGLT2 inhibitors and the addition of biguanides will be evaluated after 1, 3 and 6 months.
Key secondary outcomes
1: Comparing the difference in body weight and/or BMI between the addition of SGLT2 inhibitors and the addition of biguanides will be evaluated after 1, 3 and 6 months.
2: Comparing the difference in several factors as follow between the addition of SGLT2 inhibitors and the addition of biguanides will be evaluated after 1, 3 and 6 months.
1.Ht
2.SBP
3.DBP
4.lipid profile
5.eGFR
6.AST, ALT, GGT
7.FIB-4 index
8.UA
3: Association the change of HbA1c and several factors as follow between two groups.
1.Ht
2.SBP
3.DBP
4.lipid profile
5.eGFR
6.AST, ALT, GGT
7.FIB-4 index
8.UA
9.body weight, BMI
10.detail of medication and number of take medicine
11.detail of the diabetic macro- or micro-vascular complication and number of complications.
4: Association the change of body weight and several factors as follow between two groups.
1.Ht
2.FPG
3.HbA1c
4.SBP
5.DBP
6.lipid profile
7.eGFR
8.AST, ALT, GGT
9.FIB-4 index
10.UA
11.detail of medication and number of take medicine
12.detail of the diabetic macro- or micro-vascular complication and number of complications.
The selection criteria for the subjects are as follow.
1. Patients who have been diagnosed as type 2 diabetes.
2. Over 20 years old.
The exclusion criteria for the subjects are as follow.
1. Subjects with acute and/or chronic inflammation
2. Subjects with fresh cardiovascular and/or cerebrovascular diseases
3. Subjects with liver cirrhosis.
4. Subjects with severe respiratory disease or severe heart failure
5. Subjects with alcoholicsm or medicinal intoxication
6. Subjects with psychosis
7. Subjects who doctors judge as unfitness
Management information
Registered date
| 2022 | Year | 04 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054143
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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