Unique ID issued by UMIN | UMIN000005283 |
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Receipt number | R000004639 |
Scientific Title | Effect of DPP-4 inhibitor on insulin secretion and insulin sensitivity |
Date of disclosure of the study information | 2011/03/22 |
Last modified on | 2015/03/21 10:23:27 |
Effect of DPP-4 inhibitor on insulin secretion and insulin sensitivity
3S-OGTT (Staitama Sitagliptin Study with OGTT)
Effect of DPP-4 inhibitor on insulin secretion and insulin sensitivity
3S-OGTT (Staitama Sitagliptin Study with OGTT)
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To examine effects of sitagliptin (a DPP-4 inhibitor) and mitilinide (a glinide compound) on insulin secretion and insulin sensitivity modified by glucagon secretion during OGTT (oral glucose tolerance test)
Efficacy
AUC (area under the curve) of glucagon response during OGTT between sitagliptin treatment and miglitol treatment
Markers of insulin secretion and insulin sensitivity and relation between those markers and effect of medication on glycoalbumin, fasting plasma glucose, and 2hr plasma glucose.
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Subjects who assigned to sitagliptin first, will receive 50mg of sitagliptin per day for 7 days and 100mg of sitaglipitn for additional 7 days. Then they will receive 10mg of mitiglinide tid for 14 days.
Subjects who assigned to mitiglinide first, will receive 10mg of mitiglinide tid for 14 days. Then they will receive days50mg of sitagliptin per day for 7 days and 100mg of sitaglipitn for additional 7 days.
20 | years-old | <= |
75 | years-old | > |
Male and Female
Subjects should be type 2 diabetic patients who have stable glycemic control for more than 2 months, and their HbA1c (NSGP) should be less than 9.4 %. Subjects who are taking pioglitazone or metformin with DPP-4 inhibitors or glinides will be also enrolled.
1) Under the treatment with insulin
2) Type 1 diabetic subjects or diabetic subjects who have HbA1c (NSGP) more than or equal to 9.4 % or who need admission because of diabetic ketoacidosis or extreme hyperglycemia.
3) Subjects with alpha glucosidase inhibitors.
4) Subjects who are treated with sulfonylureas (i.e. glibenclamide, glimepiride, or gliclazide).
5) Subjects with nephrotic syndrome (urine protein more than or equal to 3.5g/day and serum protein less than or equal to 6.0 g/dl [or serum albumin less than or equal to 3.0 g/dl].
6) Subjects who are taking steroids, immune suppression medication, antifungal medication of azoles. HIV protease inhibitors
7) Subjects with previous serious adverse events (possible and prolonged situations to influence usual daily activity or to add hospital admission duration) with DPP-4 inhibitors and glinides.
8) Subjects who had brain stroke or acute coronary syndrome within 6 months before enrollment.
9) Subjects with severe heart failure (NYHA class 3 or higher), severe arrhythmia (frequent atrial or ventral arrhythmia, continuous ventricular tachycardia, severe atrial tachycardia, atrial fibrillation or flutter with severe tachycardia, sick sinus syndrome or atrial-ventral block with severe bradycardia).
10) Subjects who have AST or ALT more than 5 times of upper normal limit of their institute
11) Subjects with malignancy
12) Subjects who are pregnant or who have intention to be pregnant
13) Subjects with other situations under which a doctor in charge decides that subjects are not eligible for this study.
20
1st name | |
Middle name | |
Last name | Masafumi Matsuda |
Saitama Medical Center, Saitama Medical University
Department of Endocrinology and Diabetes
1981 Kamoda, Kawagoe-shi, Saitama-ken
049-228-3564
matsudam-ind@umin.ac.jp
1st name | |
Middle name | |
Last name | Masafumi Matsuda |
Saitama Medical Center, Saitama Medical University
Department of Endocrinology and Diabetes
1981 Kamoda, Kawagoe-shi, Saitama-ken
049-228-3564
http://www.glucose-clamp.com/isir
isir@glucose-clamp.com
Study group of incretin in Saitama
The Waksman Foundation of Japan INC.
Non profit foundation
None
None
NO
埼玉医科大学総合医療センター
2011 | Year | 03 | Month | 22 | Day |
http://www.glucose-clamp.com/isir
Published
http://www.glucose-clamp.com/isir/index.html
We compared directly these sitagliptin (SIT) and mitiglinide (MIT) in 16 type 2 diabetic patients (M/F=10/6, Age: 66+/-3 y.o., BMI: 24+/-4kg/m2, HbA1c: 6.6+/-0.5%, FPG: 116+/-27mg/dl). Patients received SIT (50mg qd for 1 week and 100mg qd for an additional week) or MIT (10mg tid for 2 weeks). After 2 weeks, patients crossed-over to an alternative treatment. 75 g oral glucose tolerance tests (OGTT) were conducted before the study and after interventions. The average of area under the curve (aAUC) up to 180 min of PG response was similar in both agents and lower than before (CON) (SIT 179+/-53, MIT 174+/-50 vs CON 222+/-60 mg/dl, p<0.0001). Insulinogenic index was highest in MIT (0.3+/-0.3 vs SIT 0.2+/-0.2, p<0.01; vs CON 0.1+/-0.1, p<0.01), while the Matsuda index was similar in 3 OGTTs (MIT 10+/-5, SIT 11+/-7, CON 11+/-7). aAUC of GLP-1 was increased in SIT (15+/-14 vs MIT 6+/-5, p<0.001; vs CON 5+/-4 pmol/L, p<0.001). The incremental aAUC of glucagon was lower in SIT (-2.4+/-12.9 vs MIT 6.2+/-14.0, p<0.05; vs CON -0.7+/-15.0 ng/ml), although basal glucagon levels were paradoxically higher in SIT (77+/-17, vs MIT 71+/-18 p<0.05; vs CON 74+/-20 ng/ml). aAUC of proinsulin was decreased in SIT (15.0+/-3 8, vs MIT 21.4+/-9.8, p<0.01; vs CON 17.2+/-8.6 pmol/L, p<0.05). Triglyceride levels were reduced by MIT. There were no differences between subjects who randomly started with SIT first and those with MIT first. While clinical doses of SIT and MIT resulted in a similar PG control, SIT enhanced less insulin secretion with less glucagon responses and much less proinsulin responses compared with MIT. Thus these changes of hormonal profiles by SIT favor islet functions compared with MIT in clinical use.
Completed
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
Published :
Yoshitaka Akiyama, Tomoko Morita-Ohkubo, Natsuko Oshitani, Yuko Ohno, Yoshimasa Aso, Toshihiko Inukai, Masafumi Kakei, Masanobu Kawakami, Takuya Awata, Shigehiro Katayama and Masafumi Matsuda: Decreased glucagon levels and decreased insulin secretion after sitagliptin versus mitiglinide administration with similar glycemic levels following an oral glucose load: a randomized crossover pharmaceutical mechanistic study. Diabetology International 10.1007/s13340-015-0207-1
2011 | Year | 03 | Month | 21 | Day |
2015 | Year | 03 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004639
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