UMIN-CTR Clinical Trial

Public title

Liraglutide versus insulin detemir , the effective switch from intensive insulin therapy to the once-daily injection in patients with well controlled type 2 diabetes : a randomized controlled trial

Acronym

Liraglutide versus insulin detemir , the effective switch from intensive insulin therapy to the once-daily injection

Scientific Title

Liraglutide versus insulin detemir , the effective switch from intensive insulin therapy to the once-daily injection in patients with well controlled type 2 diabetes : a randomized controlled trial

Scientific Title:Acronym

Liraglutide versus insulin detemir , the effective switch from intensive insulin therapy to the once-daily injection

Region

Japan

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to compare the effect of liraglutide and insulin detemir switched from intensive insulin therapy on glycemic control in patients with type 2 diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

HbA1c at 0, 8, 16 and 24 weeks after administration of liraglutide or insulin detemir.

Key secondary outcomes

Fasting plasma glucose and self-monitoring blood glucose and body weight at 0, 8, 16 and 24 weeks after administration of liraglutide or insulin detemir , Diabetes treatment satisfaction questionnaire (DTSQ) , Frequency of side effects (digestive symptoms, hypoglycemia)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Detemir group
1.Intensive insulin therapy is discontinued.
2.The starting dose of insulin detemir is not changed. Add on sitagliptin (50 mg/day).
3.During the first 8 weeks, insulin detemir is titrated once two weeks by patients, based on self-measured FPG, aiming for a target value of 90 <= FPG <= 130 mg/dl.

Interventions/Control_2

Liraglutide group
1.Intensive insulin therapy is discontinued
2.Starting at 0.3mg once daily with weekly increments of 0.3mg , reaching a final daily dose of 0.9mg by the end of the second week.
3.At 4 and 8 weeks, if FPG is > 160mg/dl , add on glimepiride 0.5mg and the dose is increased up to 1.0mg if necessary.

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

Patients whose HbA1c(JDS) were <= 6.9%
on intensive insulin therapy with insulin dose of <= 30 units.

Key exclusion criteria

1. Patients with history of diabetic ketoacidosis, or diabetic coma within 6 months prior to the study entry.
2. Patients with during pregnancy or lactation.
3. severe infection, before operation, severe trauma
4. Patients who received steroid therapy
5. Patients with history of cardiac failure.
6. Patients with renal insufficiency (serum creatinine > 1.5mg/dl (male) , > 1.3mg/dl (female), e-GFR < 50ml/min).
7. Patients with severe liver dysfunction.
8. Patients with type1 diabetes.
9. Patients with disorder of insulin secretion (serum C-peptide < 0.5ng/ml)
10. Patients who are hypersensitive to these medicines
11. Patients judged to be inappropriate by physicians in charge.

Target sample size

90

Name of lead principal investigator

1st name
Middle name
Last name	Yasuo Terauchi

Organization

Yokohama City Unuversity Graduate School of Medicine

Division name

Department of Endcrinology & Metabolism

Zip code

Address

3-9 Fukuura, Kanazawa-Ku, Yokohama City 236-0004

TEL

0457872800

Email

terauchi-tky@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Yuichiro Inoue

Organization

Yokohama City Unuversity Graduate School of Medicine

Division name

Department of Endcrinology & Metabolism

Zip code

Address

3-9 Fukuura, Kanazawa-Ku, Yokohama City 236-0004

TEL

0457872800

Homepage URL

Email

hiroshic_w@yahoo.co.jp

Institute

Yokohama City Unuversity Graduate School of Medicine

Institute

Department

Personal name

Organization

None

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

茅ケ崎市立病院（神奈川県）、関東労災病院（神奈川県）

Date of disclosure of the study information

2012

Year

01

Month

04

Day

URL releasing protocol

Publication of results

Published

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

2012

Year

01

Month

01

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

01

Month

04

Day

Last modified on

2017

Year

07

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008244