Unique ID issued by UMIN | UMIN000007926 |
---|---|
Receipt number | R000008681 |
Scientific Title | Study of Sitagliptin Treatment for Glycemic Control and Prevention of GAD-Ab Positive Non-insulin Dependent Diabetes Mellitus in Osaka |
Date of disclosure of the study information | 2012/05/11 |
Last modified on | 2012/05/06 18:57:06 |
Study of Sitagliptin Treatment for Glycemic Control and Prevention of GAD-Ab Positive Non-insulin Dependent Diabetes Mellitus in Osaka
STGP-OSAKA
Study of Sitagliptin Treatment for Glycemic Control and Prevention of GAD-Ab Positive Non-insulin Dependent Diabetes Mellitus in Osaka
STGP-OSAKA
Japan |
GAD-Ab positive non-insulin dependent diabetes mellitus
Endocrinology and Metabolism |
Others
NO
Comparison of sitagliptin versus insulin on Glycemic Control and Prevention of GAD-Ab Positive Non-insulin Dependent Diabetes Mellitus
Efficacy
Change of patients indicated an insulin-dependent state during 3 years.
Rate of patients indicated an insulin-dependent state.
Change of HbA1c value.
Change of Fasted plasma glucose, Fasted serum CPR value.
Glucose level, glucagon level and C-peptide values during the liquid mixed-meal test.
Average amount of insulin per a day.
Rate of hypoglycemia. etc
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Central registration
2
Treatment
Medicine |
Sitagliptin group
Sitagliptine begin with 50 mg once daily (max dose 100mg).
Addition of metformin and/or alpha-GI are possible after increasing the dose of sitagliptine to 100mg.
Control group
Subcutaneous insulin administration to the control group patients. The dosage is adjusted.
If necessary, addition of metformin and/or alpha-GI are possible.
20 | years-old | <= |
80 | years-old | > |
Male and Female
Patients who met the criteria for diabetes mellitus.
1. Duration of diabetes should be within 5 yr from onset (or diagnosis).
2. GADAb positive: 1.5U/ml or higher
3. fasting serum C-peptide: 0.5ng/ml or higher
4. HbA1c(NGSP): <8.4%
FPG: <160mg/dl
1. Injection of insulin within 3 month before entry point
2. Pregnant or planning to be pregnant
3. Diabetic nephropathy: Class 3 or higher
4. Diabetic retinopathy:
Preproliferative or higher
5. NYHA 3-4
6. History in use of DPP-4 inhibitor or GLP-1 analogue.
7. Physician's judgment.
40
1st name | |
Middle name | |
Last name | Mitsuyoshi Namba |
Hyogo College of Medicine
Division of Diabetes and Metabolism, Department of Internal Medicine
1-1, Mukogawa-chi, Nishinomiya, Hyogo, 663-8501 Japan
1st name | |
Middle name | |
Last name | Jun-ichiro Miyagawa |
Hyogo college of medicine
Division of Diabetes and Metabolism, Department of Internal Medicine
1-1, Mukogawa-chi, Nishinomiya, Hyogo, 663-8501 Japan
0798-45-6111
STGP-OSAKA study group
None
Self funding
NO
2012 | Year | 05 | Month | 11 | Day |
Unpublished
Enrolling by invitation
2012 | Year | 02 | Month | 03 | Day |
2012 | Year | 04 | Month | 01 | Day |
2012 | Year | 05 | Month | 10 | Day |
2012 | Year | 05 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008681