Unique ID issued by UMIN | UMIN000017298 |
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Receipt number | R000019104 |
Scientific Title | Dietary impacts on glucose-lowering effects of sitagliptin in type 2 diabetes; a randomized, prospective, open-label clinical study |
Date of disclosure of the study information | 2015/04/27 |
Last modified on | 2018/06/23 22:23:12 |
Dietary impacts on glucose-lowering effects of sitagliptin in type 2 diabetes; a randomized, prospective, open-label clinical study
Dietary impacts on glucose-lowering effects of sitagliptin in type 2 diabetes (DIET)
Dietary impacts on glucose-lowering effects of sitagliptin in type 2 diabetes; a randomized, prospective, open-label clinical study
Dietary impacts on glucose-lowering effects of sitagliptin in type 2 diabetes (DIET)
Japan |
Diabetes Mellitus, Type 2
Endocrinology and Metabolism |
Others
NO
In a prospective, randomized case-controlled study, the investigators hope to demonstrate a positive correlation of plasma levels of EPA and DHA as well as fish intake with the HbA1c-lowering effect of sitagliptin but not with the active comparator glimepiride.
Efficacy
Exploratory
Phase IV
Correlation of plasma levels of EPA and DHA with changes in HbA1c levels from baseline to week 16 in each treatment group with sitagliptin and glimepiride
Correlation of estimated fish intake with changes in HbA1c levels from baseline to week 16 in each treatment group with sitagliptin and glimepiride
Identification of blood metabolite correlating with changes in HbA1c levels from baseline to week 16 in each treatment group with sitagliptin and glimepiride
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Sitagliptin: Januvia 50 mg a day for 16 weeks
Glimepiride: Amaryl 0.5 mg a day for 16 weeks
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Japanese T2DM patient
2) OAD naive or receive 4-week wash out of one OAD (glinides, alpha-GI, metformin) before randomization
3)HbA1c 6.0-8.0%
4)BMI 18-30kg/m2
5)Age 20-75
6)CrCl 60mL/min or above
1)Patients on DPP-4 inhibitors or glimepiride
2)Patients treated with pioglitazone within the last 8 weeks
3)Patients with moderate/severe renal impairments (CrCl: < 60mL/min)
4)Patients with insulin or GLP-1 receptor agonists
5)Patients with a history of cerebrovascular disorder or cardiovascular disturbance
Patients with heart failure (NYHA I-IV)
6)Patients with severe hepatic dysfunction
7)Patients with a history of pancreatitis
8)Patients with diabetic retinopathy
9)Patients with a history of gastrointestinal surgery
10)Patients with a history of malignancy within the last 5 yrs
11)Patients with severe infection, severe injury or before/after operation
12)Patients with excessive drinking habit
13)Male: Hb < 13.0 g/dl,
Female: Hb < 12.5 g/dl
14)Patients with a difficulty to follow instructions by investigators
15)Patients participating in any other clinical study
16)Pregnancy
17)Patients judged ineligible by investigators
48
1st name | |
Middle name | |
Last name | Yutaka Seino |
Kansai Electric Power Hospital
Center for Diabetes, Endocrinology and Metabolism
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
06-6458-5821
seino.yutaka@e2.kepco.co.jp
1st name | |
Middle name | |
Last name | Daisuke Yabe |
Kansai Electric Power Hospital
Center for Diabetes, Endocrinology and Metabolism
2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
06-6458-5821
ydaisuke-kyoto@umin.ac.jp
Kansai Electric Power Hospital
MSD K.K.
Profit organization
Japan
Saiseikai Noe Hospital
YES
NCT02312063
ClinicalTrials.gov
関西電力病院(大阪府)、大阪府済生会野江病院(大阪府)
2015 | Year | 04 | Month | 27 | Day |
Unpublished
Completed
2014 | Year | 10 | Month | 20 | Day |
2015 | Year | 03 | Month | 16 | Day |
2016 | Year | 10 | Month | 07 | Day |
2018 | Year | 03 | Month | 31 | Day |
2015 | Year | 04 | Month | 27 | Day |
2018 | Year | 06 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019104
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