UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007009
Receipt number R000008244
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
Date of disclosure of the study information 2012/01/04
Last modified on 2017/07/09 09:51:41

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Basic information

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

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

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)


Base

Study type

Interventional


Study design

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


Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Yokohama City Unuversity Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

茅ケ崎市立病院(神奈川県)、関東労災病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2012 Year 01 Month 04 Day


Related information

URL releasing protocol


Publication of results

Published


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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name