UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002077
Receipt number R000002532
Scientific Title A multi-center, open label, observational trial to evaluate efficacy and safety of stepwise insulin treatment as add-on to current OAD therapy in subjects with type 2 diabetes mellitus.
Date of disclosure of the study information 2009/06/17
Last modified on 2013/07/22 11:46:07

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Basic information

Public title

A multi-center, open label, observational trial to evaluate efficacy and safety of stepwise insulin treatment as add-on to current OAD therapy in subjects with type 2 diabetes mellitus.

Acronym

A multi-center, open label, observational trial to evaluate efficacy and safety of stepwise insulin treatment as add-on to current OAD therapy in subjects with type 2 diabetes mellitus (STEADY study).

Scientific Title

A multi-center, open label, observational trial to evaluate efficacy and safety of stepwise insulin treatment as add-on to current OAD therapy in subjects with type 2 diabetes mellitus.

Scientific Title:Acronym

A multi-center, open label, observational trial to evaluate efficacy and safety of stepwise insulin treatment as add-on to current OAD therapy in subjects with type 2 diabetes mellitus (STEADY study).

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To demonstrate efficacy and safety of initiation using once-daily long acting insulin analogue; insulin detemir (Levemir) and effect of treat-to-target in type 2 diabetes mellitus who do not reach target HbA1c.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Percentage of patients who reach target HbA1c under 6.5%

Key secondary outcomes

1. Change of HbA1c, 1.5AG, fasting plasma glucose, 7-point SMBG, 2-hour postprandial glucose level
2. Hypoglycemia episodes and other adverse events
3. Markers of cardiovascular risk [Human sensitive C-reactive peptide (hsCRP), Soluble Intercellular Adhesion Molecule(sICAM), soluble vascular cell adhesion molecule 1 (sVCAM-1) and von Willebrand Factor (vWF)]
4. Circumference of waist and hip
5. Change of height, weight, BMI
6. Change of insulin dose (total dose, basal dose, bolus dose)
7. Change of patients' QOL and satisfaction


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. A consent form for participating in this study is submitted
2. Patients diagnosed with type 2 diabetes in more than 6 months
3. Males and females of age >= 18 years
4. HbA1c >= 7.0 %, <=10.0%
5. Insulin na&iuml;ve patients
6. Patients treated using one or more oral anti-diabetes drugs below:
-Metoformine
-Sulfonil-urea
-Pioglitazone
7. Patients able and willing to perform self-monitoring of blood glucose

Key exclusion criteria

1. Patients who have experience of insulin treatment
2. Pregnant, or intention of becoming pregnant.
3. Patients who are judged by investigators as inappropriate subject to participant this trail.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiko Iwamoto

Organization

Tokyo Women's Medical University

Division name

Diabetes Center

Zip code


Address

8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-8111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Tomoko Nakagami

Organization

Tokyo Women's Medical University

Division name

Diabetes Center

Zip code


Address

8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-8111

Homepage URL


Email

nakagami@dmc.twmu.ac.jp


Sponsor or person

Institute

Tokyo Women's Medical University

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

三井ビルクリニック(東京都)、至誠会第二病院(東京都)、ともながクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2009 Year 06 Month 17 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

Forty-nine patients with type 2 diabetes were enrolled and 43 completed this study.
In Phase 1 (once-daily basal insulin therapy), HbA1c was significantly reduced from 8.4% at baseline to 7.8% at six-month (p<0.001). Six subjects out of 43 (14.0%) have achieved the HbA1c target of <6.9%.
Thirty-seven subjects who could not achieve the HbA1c target in Phase 1, continued the study by using steped up regimen (once-daily basal insulin plus once-daily bolus insulin therapy). HbA1c was significantly reduced from 8.4% at baseline to 7.8% at twelve-month (p=0.001). Six subjects out of 37 (16.2%) have achieved the HbA1c target of <6.9%.
No major hypoglycemic events were reported. Minorhypoglycemic events were reported more frequent in Phase 2(0.27-0.34 events/patients*month) than Phase 1(0.07-0.14 events/patients*month).

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

2008 Year 12 Month 10 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry

2011 Year 04 Month 01 Day

Date trial data considered complete

2011 Year 04 Month 01 Day

Date analysis concluded

2011 Year 05 Month 01 Day


Other

Other related information

Random-sampling prospective observational study


Management information

Registered date

2009 Year 06 Month 15 Day

Last modified on

2013 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002532


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name