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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005283
Receipt No. 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

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Basic information
Public title Effect of DPP-4 inhibitor on insulin secretion and insulin sensitivity
Acronym 3S-OGTT (Staitama Sitagliptin Study with OGTT)
Scientific Title Effect of DPP-4 inhibitor on insulin secretion and insulin sensitivity
Scientific Title:Acronym 3S-OGTT (Staitama Sitagliptin Study with OGTT)
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AUC (area under the curve) of glucagon response during OGTT between sitagliptin treatment and miglitol treatment
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Matsuda
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Endocrinology and Diabetes
Zip code
Address 1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL 049-228-3564
Email matsudam-ind@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Matsuda
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Endocrinology and Diabetes
Zip code
Address 1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL 049-228-3564
Homepage URL http://www.glucose-clamp.com/isir
Email isir@glucose-clamp.com

Sponsor
Institute Study group of incretin in Saitama
Institute
Department

Funding Source
Organization The Waksman Foundation of Japan INC.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 埼玉医科大学総合医療センター

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 22 Day

Related information
URL releasing protocol http://www.glucose-clamp.com/isir
Publication of results Published

Result
URL related to results and publications http://www.glucose-clamp.com/isir/index.html
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information 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

Management information
Registered date
2011 Year 03 Month 21 Day
Last modified on
2015 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004639

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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