Unique ID issued by UMIN | UMIN000002077 |
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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 |
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.
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).
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.
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).
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
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.
Safety,Efficacy
Percentage of patients who reach target HbA1c under 6.5%
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
Observational
18 | years-old | <= |
Not applicable |
Male and Female
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 naïve 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
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.
50
1st name | |
Middle name | |
Last name | Yasuhiko Iwamoto |
Tokyo Women's Medical University
Diabetes Center
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
03-3353-8111
1st name | |
Middle name | |
Last name | Tomoko Nakagami |
Tokyo Women's Medical University
Diabetes Center
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
03-3353-8111
nakagami@dmc.twmu.ac.jp
Tokyo Women's Medical University
None
Self funding
NO
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)
2009 | Year | 06 | Month | 17 | Day |
Published
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).
Completed
2008 | Year | 12 | Month | 10 | Day |
2010 | Year | 07 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 05 | Month | 01 | Day |
Random-sampling prospective observational study
2009 | Year | 06 | Month | 15 | Day |
2013 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002532
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