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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002077
Receipt No. 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

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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
Institute Tokyo Women's Medical University
Institute
Department

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
URL(English) https://upload.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


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