Unique ID issued by UMIN | UMIN000003563 |
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Receipt number | R000004321 |
Scientific Title | Intervention of Type 2 DM with Sitagliptin or High dose Metformin Trial in Kobe:INSIGHT-KOBE |
Date of disclosure of the study information | 2010/05/06 |
Last modified on | 2010/11/03 09:17:33 |
Intervention of Type 2 DM with Sitagliptin or High dose Metformin Trial in Kobe:INSIGHT-KOBE
Intervention of Type 2 DM with Sitagliptin or High dose Metformin Trial in Kobe:INSIGHT-KOBE
Intervention of Type 2 DM with Sitagliptin or High dose Metformin Trial in Kobe:INSIGHT-KOBE
Intervention of Type 2 DM with Sitagliptin or High dose Metformin Trial in Kobe:INSIGHT-KOBE
Japan |
Type 2 Diabetes Mellitus
Endocrinology and Metabolism |
Others
NO
To compare the effectiveness of beta cell reservation
Efficacy
change in CPR index during 3years
1. duration to monotherapy failure
2. HbA1c, MAGE obtained from SMBG
3. new onset or progression of micro, macrovascular complication
4. HOMA beta, HOMA-R, proinsulin/insulin ratio
5. adverse event and body weight change
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
start with Sitagliptin 50 mg/day and up to 100 mg/day
start with Metformin 500 mg/day and up to 1500 mg/day
20 | years-old | <= |
80 | years-old | > |
Male and Female
1. treated only with life style modification (or cesssation of previous treatment for more than 1 month)
2. obtained documented agreement
3. patients between 20 and 35
4. HbA1c (JDS) between 6.5% and 8.0%
1. Type 1 diabetes and diabetes by other etiology
2. anti GAD antibogy positive (over1.5 U/ml)
3. allegy for sitagliptin or metformin
4. severe liver dysfunction
5. severe renal dysfunction
6. severe heart failure
7. poor prognosis condition (ex: malignancy)
8. pregnancy or breast-feeding woman
9. metabolic emergency (DKA, HHS)
10. insulin user
11.psychological disorder
12. hypoglycemia unawareness
13. steroid user
14. other improper patient
200
1st name | |
Middle name | |
Last name | Kazuhiko Sakaguchi |
Kobe University Graduate School of Medicine
Division of diabetes and metabolism
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
078-382-5861
1st name | |
Middle name | |
Last name | Kazuhiko Sakaguchi |
Kobe University Graduate School of Medicine
Division of diabetes and metabolism
kzhkskgc@med.kobe-u.ac.jp
INSIGHT-KOBE Investigators
Diabetes Foundation
Non profit foundation
NO
2010 | Year | 05 | Month | 06 | Day |
Unpublished
Open public recruiting
2010 | Year | 06 | Month | 30 | Day |
2010 | Year | 08 | Month | 01 | Day |
2010 | Year | 05 | Month | 03 | Day |
2010 | Year | 11 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004321
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