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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035791
Receipt No. 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 2019/08/08

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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
Email 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
Email onyogora@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

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
Email 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
2023 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
2019 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040746

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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