UMIN-CTR Clinical Trial

Public title

Efficacy of canagliflozin versus liraglutide, alternative to bolus insulin in patients with basal-bolus regimen.

Acronym

Efficacy of canagliflozin versus liraglutide, alternative to bolus insulin in patients with basal-bolus regimen (ECLIPS).

Scientific Title

Efficacy of canagliflozin versus liraglutide, alternative to bolus insulin in patients with basal-bolus regimen.

Scientific Title:Acronym

Efficacy of canagliflozin versus liraglutide, alternative to bolus insulin in patients with basal-bolus regimen (ECLIPS).

Region

Japan

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to assess the efficacy and safety of canagliflozin versus liraglutide, alternative to bolus insulin in patients with basal-bolus regimen.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The reduction degree of the HbA1c in 12 and 24 weeks.

Key secondary outcomes

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

The group which changes ultra-rapid insulin to canagliflozin 100mg p.o. for 24 weeks.

Interventions/Control_2

The group which changes ultra-rapid insulin to liraglutide 0.9mg s.c. for 24 weeks.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) We screened type 2 diabetic patients who regularly attended Toho University Oomori Hospital.
(2) Disease duration 1 to 25 years.
(3) Patient taking basal-bolus insulin therapy, with insulin glargine or insulin degurudegu, and ultra-rapid insulin more than 6 months.
(4) Glycated hemoglobin (HbA1c) of less than 7.5%, and stable glycemic control with HbA1c variation less than 1.0% during the preceding 2 months.
(5) Body mass index (BMI) is over 22.
(6) Negative history of GLP-1 agonist.
(7) Patient taking equal or less than two kinds of oral anti-diabetes drugs, except DPP-4 inhibitor or SGLT2 inhibitor.
(8) Adults who are 20 years or older.
(9) Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination.

Key exclusion criteria

(1) Type 1 diabetes mellitus patients or steroid induced diabetes mellitus.
(2) Patients with aspartate aminotransferase or alanine aminotransferase more than 100 IU/L.
(3) Patients with plasma creatinine more than 2.0mg/dL.
(4) Patients who had myocardial infarction within 3 months.
(5) Patients with severe pancreas disease
(6) Patients taking cancer treatment
(7) Patients with hemoglobin (Hb) less than 11 g/dL.
(8) Patients whose the number of the platelets is less than 100,000 /mm3.
(9) Patients with severe diabetic neuropathy
(10) Patients having proliferative retinopathy.
(11) Patients with serious infectious disease or operative state.
(12) Patients with inflammatory bowel disease and chronic bowel disease.
(13) Heavy alcohol drinkers.
(14) Patients who are pregnant, hope to be pregnant, or are in lactation period.
(15) Patients with positive of HBV or HCV.
(16) In addition, the patients who will be judged inappropriate by an attendant physician.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Takahisa Hirose

Organization

Toho University School of Medicine

Division name

Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine

Zip code

Address

6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541,Japan

TEL

03-3762-4151

Email

yasuyo@med.toho-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yasuyo Ando

Organization

Toho University School of Medicine

Division name

Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine

Zip code

Address

6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541,Japan

TEL

03-3762-4151

Homepage URL

Email

yasuyo@med.toho-u.ac.jp

Institute

Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Toho University School of Medicine

Institute

Department

Personal name

Organization

Toho University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2015

Year

10

Month

16

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

2015

Year

09

Month

17

Day

Date of IRB

Anticipated trial start date

2015

Year

10

Month

19

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

16

Day

Last modified on

2018

Year

10

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022411