UMIN-CTR Clinical Trial

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

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Yokohama City University

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Chigasaki Municipal Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

11

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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