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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024164
Receipt No. R000027238
Scientific Title Effects of dulaglutide and trelagliptin on beta-cell function in patients with type 2 diabetes: a randomized controlled study
Date of disclosure of the study information 2016/11/29
Last modified on 2017/11/16

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Basic information
Public title Effects of dulaglutide and trelagliptin on beta-cell function in patients with type 2 diabetes: a randomized controlled study
Acronym DUET-beta study
Scientific Title Effects of dulaglutide and trelagliptin on beta-cell function in patients with type 2 diabetes: a randomized controlled study
Scientific Title:Acronym DUET-beta study
Region
Japan

Condition
Condition Type 2 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 once-weekly GLP-1 receptor agonist dulaglutide and once-weekly DPP-4 inhibitor trelagliptin on beta-cell function in patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparing the two groups of change in beta-cell function over the 24-week treatment period, measured using the disposition index.
Key secondary outcomes Change in next items between baseline and 24 weeks of treatment.

1. HOMA2-%beta (%)
2. HOMA2-IR
3. CPR-index
4. Change in CPR during glucagon stimulation test
5. Area under the curve of C-peptide during glucagon stimulation test
6. HbA1c
7. Glycated alubumin
8. Fasting plasma glucose
9. Self-measured postprandial glucose
10. Systolic blood pressure
11. Diastolic blood pressure
12. Pulse rate
13. Lipid profile
14. eGFR
15. Urine albumin/creatinine ratio
16. Basal insulin dose
17. Body weight
18. Waist circumference
19. Fat mass
20. Skeletal muscle mass
21. Hypoglycemic events
22. Medication compliance
23. Other adverse events

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 Dulaglutide 0.75mg/week, 24 weeks
Interventions/Control_2 Trelagliptin 100mg/week, 24 weeks

(CCr <50ml/min/1.73m2, reduce dose to 50mg/week)
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. Age between 20 and 85 years
2. Both gender
3. Treated with metformin +/- basal insulin
4. Stable treatment for diabetes over 8 weeks
5. Fasting plasma glucose level between 70 mg/dL and 180 mg/dL at screening
6. HbA1c less than 9.5% at screening
Key exclusion criteria 1. Treated with incretin-based therapy
2. Type 1 diabetes or secondary forms of diabetes
3. Renal dysfunction (eGFR <35 ml/min/1.73m2)
4. Hepatic dysfunction (AST and/or ALT >3X upper limit of normal)
5. Malignant neoplasm
6. Severe infection or injury
7. Hypersensitivity to dulaglutide or trelagliptin
8. Pregnant or willing to be pregnant during this study
9. Unable to obtain informed consent to this study
10. Unable to maintain compliance during this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Kondo
Organization Graduate School of Medicine, Yokohama City University
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fuku-ura Kanazawa-ku Yokohama Kanagawa Japan
TEL 045-787-2639
Email kondo-ycu@zay.att.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinobu Kondo
Organization Graduate School of Medicine, Yokohama City University
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fuku-ura Kanazawa-ku Yokohama Kanagawa Japan
TEL 045-787-2639
Homepage URL
Email kondo-ycu@zay.att.ne.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Chigasaki Municipal Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 横浜市立大学附属病院(神奈川県)
茅ヶ崎市立病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 29 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 Completed
Date of protocol fixation
2016 Year 09 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 29 Day
Last follow-up date
2017 Year 09 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 26 Day
Last modified on
2017 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027238

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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