UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024164
Receipt number 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 13:50:28

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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 or person

Institute

Yokohama City University

Institute

Department

Personal name



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

Value
https://center6.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