UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035791 |
|---|---|
| Receipt number | R000040746 |
| Scientific Title | Effects of Metformin, Sitagliptin and Empagliflozin as the first therapy for patients with type 2 diabetes: a randomized controlled study: MOSEL-first study |
| Date of disclosure of the study information | 2019/02/06 |
| Last modified on | 2022/08/27 15:47:19 |
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Basic information
Public title
Effects of Metformin, Sitagliptin and Empagliflozin as the first therapy for patients with type 2 diabetes: a randomized controlled study: MOSEL-first study
Acronym
MOSEL-fisrt study
Scientific Title
Effects of Metformin, Sitagliptin and Empagliflozin as the first therapy for patients with type 2 diabetes: a randomized controlled study: MOSEL-first study
Scientific Title:Acronym
MOSEL-fisrt study
Region
| Japan |
Condition
Condition
Type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to compare the effects of metformin, DPP-4 inhibitor sitagliptin, SGLT-2 inhibitor empagliflozin as an initial treatment for non-drug-treated patients with type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of change in HbA1c at 24 weeks by metformin, sitagliptin and empagliflozin
Key secondary outcomes
Change in next items between baseline and 24,48,96weeks of treatment.
1. HbA1c
2. Glycated albumin
3. Fasting plasma glucose
4. Fasting C-peptide
5. creatinine
6. eGFR
7. Urine albumin/creatinine ratio(ACR)
8. TG
9. HDL-C
10. LDL-C
11. HOMA2%B
12. HOMA2-IR
13. Systolic blood pressure
14. Diastolic blood pressure
15. Pulse rate
16. Body weight
17. Medication compliance
18. Frequency of use(introduction)of insulin(Insulin is introduced in each group when blood glucose control is insufficient after the start of the study).
19. Stratified analysis on HbA1c variation(baseline HbA1c,BMI and age).
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Metformin is started at 500 mg/day and increased to 2250 mg/day.24 weeks.
Interventions/Control_2
Sitagliptin is started at 50 mg/day and increased to 100 mg/day when HbA1c at 12 weeks intervention is over 8.0%. 24 weeks.
Interventions/Control_3
Empagliflozin is started at 10 mg/day and increased to 25 mg/day when HbA1c at 12 weeks intervention is over 8.0%.24 weeks.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age between 20 and 74 years
2. Patients treated by diet and exercise therapy
3. Patients who are not using hypoglycemic drugs at registration.
4. Over HbA1c 7.0%, under 11.0% at screening.
Key exclusion criteria
1.Type 1 diabetes or secondary forms of diabetes.
2. Patients who have been administered hypoglycemic drugs by oral or injection by the time of registration.
3. Renal dysfunction (eGFRcr<45 ml/min/1.73m2).
4. Hepatic dysfunction (AST and/or ALT >3X upper limit of normal).
5. Patients with dehydration, chronic diarrhea.
6. Patients who developed ischemic heart disease within 6 months.
7. Malignant neoplasm (In case of follow-up in remission phase, registration is allowed).
8. Steroid(oral/injection) patients undergoing treatment.
9. Severe infection or injury.
10. Hypersensitivity to metformin, sitagliptin, or empagliflozin.
11. Pregnant or willing to be pregnant during this study.
12. Unable to obtain informed consent to this study.
13. Unable to maintain compliance during this study.
14. Patients judged unsuitable as subjects by doctor's judgment.
Target sample size
99
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
232-0024
Address
4-57 Urafune-cho, Mimami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
naibunpi@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Marina |
| Middle name | |
| Last name | Harada |
Organization
Department of Endocrinology and Diabetes
Division name
Department of Endocrinology and Diabetes
Zip code
232-0024
Address
4-57 Urafune-cho, Mimami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
onyogora@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chigasaki Municipal Hospital
Urafune Kanazawa Internal Medicine Clinic
Kamiooka Diabetes and Metabolism Clinic
Fureai Yokohama Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hito wo taishoutosuru igakukeikenkyuu iinkai
Address
3-9 Urafune Kanazawa-ku Yokohama Japan
Tel
0453707627
rinri@yokohama-cu.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
横浜市立大学附属市民総合医療センター(神奈川)
茅ヶ崎市立病院(神奈川)
浦舟金沢内科クリニック(神奈川)
上大岡糖尿病・代謝内科クリニック(神奈川)
ふれあい横浜ホスピタル(神奈川)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 06 | Day |
Last modified on
| 2022 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040746
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/02/16 | MOSEL+first+study～研究計画書_Ver1.4.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/02/16 | MOSEL+first+study～研究計画書_Ver1.4.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/02/16 | MOSEL+first+study～研究計画書_Ver1.4.docx |
