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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013218
Receipt No. R000015424
Scientific Title Effects of Sitagliptin on Glycemic Control and Lipoprotein Metabolism (GLORIA)
Date of disclosure of the study information 2014/02/21
Last modified on 2018/08/03

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Basic information
Public title Effects of Sitagliptin on Glycemic Control and Lipoprotein Metabolism (GLORIA)
Acronym Effects of Sitagliptin on Glycemic Control and Lipoprotein Metabolism (GLORIA)
Scientific Title Effects of Sitagliptin on Glycemic Control and Lipoprotein Metabolism (GLORIA)
Scientific Title:Acronym Effects of Sitagliptin on Glycemic Control and Lipoprotein Metabolism (GLORIA)
Region
Japan

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

Objectives
Narrative objectives1 To examine the efficacy of Sitagliptin for improving hyperglycemia, lipoprotein metabolism and lipid oxidation markers (HETE, HODE, etc.) in patients with type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in the following items will be evaluated at the beginning of administration and after the 12th week of administration.
- Lipid oxidation markers (HODE, HETE)
Key secondary outcomes -Evaluation of following levels before and after the administration of Sitagliptin
>Fasting Glucose
>HbA1c(NGSP or JDS)
>Triglyceride, total cholesterol, HDL-cholesterol, LDL-cholesterol
>adiponectin, insulin, glucagon
>free fatty acids(FFA)
>apolipoproteinAI, AII, B, CII, CIII, E, apoB-48
>omentin, RemL-C, CystatinC, endotoxin
- Incidence of side effects (hypoglycemia)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 One 50-mg tablet of Sitagliptin will be orally administered once daily for 12 weeks. Based on the therapeutic target, the dose can be increased to 100 mg.
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with type 2 diabetes aged >20 years old who meet the following criteria and have fasting blood glucose (FPG) >126 mg/dL and HbA1c <8.4% (NGSP) or <8.0% (JDS)
Patients who have not shown a sufficient response to any of the following treatments described in the package insert
1) Diet therapy and exercise therapy only
2) Use of a sulfonylurea drug in addition to diet therapy and exercise therapy
Sulfonylurea drug (Amaryl, Euglucon, Glimicron and Daonil)
Patients who meet the following exclusion criteria will be excluded.
3) Use of a thiazolidine drug in addition to diet therapy and exercise therapy
Thiazolidine drug (Actos)
4) Use of a biguanide drug in addition to diet therapy and exercise therapy
Biguanide drug (Melbin, Glycoran, Dibetos B and Metgluco)
5) Use of an alpha-glucosidase inhibitor in addition to diet therapy and exercise therapy
alpha-glucosidase inhibitor (Basen, Seibule and Glucobay)
6) Use of an insulin product in addition to diet therapy and exercise therapy
2. Patients who give written informed consent to participate in the study on a voluntary basis after receiving and understanding a sufficient explanation of the study
Key exclusion criteria 1. Patients with type 1 diabetes
2. Patients with severe renal disorder (including hemodialysis) with a serum creatinine (Cr) level (mg/dL) >2.5 for males and >2.0 for females
3. Patients who have already received a sulfonylurea drug at a higher dose than the following dose: (Amaryl: 2 mg, Euglucon: 1.25 mg, and Glimicron: 40 mg), when it is clinically judged that the dose of the sulfonylurea cannot be decreased when sitagliptin is added. The criteria for a decrease in the dose of the sulfonylurea when sitagliptin is added are as follows:
For patients who receive glimepiride (Amaryl) at a dose of >2 mg/day, the dose should be decreased to <2 mg/day.
For patients who receive glibenclamide (Euglucon and Daonil) at a dose of >1.25 mg/day, the dose should be decreased to <1.25 mg/day.
For patients who receive gliclazide (Glimicron) at a dose of >40 mg/day, the dose should be decreased to <40 mg/day.
4. Patients who have already taken Sitagliptin, Alogliptin, or Vildagliptin.
5. Patients who newly started taking a statin, fibrate, ezetimibe, or probucol within 1 month of the start of the study
6. Patients who are pregnant or may become pregnant
7. Patients receiving treatment for thyroid failure
8. Patients with severe hepatic dysfunction with AST and ALT >100 IU/L
9. Patients who have participated in another clinical study
10. Other patients who judged not to be eligible to participate in the study by their primary physician
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shizuya Yamashita
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3633
Email shizu@cardiology.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisaku Masuda
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3633
Homepage URL
Email masuda@cardiology.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine, Department of Cardiovascular Medicine
Institute
Department

Funding Source
Organization The Supporting Center for Clinical Research and Education
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 大阪中央病院(大阪府)、蒼生病院(大阪府)、リョーヤコマツクリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/browse/jat
Number of participants that the trial has enrolled
Results In patients with type II diabetes mellitus, fasting and postprandial hypertriglyceridemia (PHTG) is complicated. PHTG is supposed to be caused by the postprandial accumulation of remnant lipoproteins (VLDL remnants and chylomicron remnants), which are highly atherogenic. In the current study, we investigated whether the sitagliptin might ameliorate the impaired lipoprotein metabolism in patients with type II diabetes mellitus. We enrolled 38 patients with type II diabetes mellitus whose HbA1c levels were less than 8.4% and all patients gave written informed consents. The oral administration of sitagliptin(50mg/day) were started in addition to the current anti-diabetic treatments. The daily dose of sitagliptin was allowed to increase up to 100 mg/day in order to achieve low HbA1c level less than 7.4%. We compared biomarkers concerning glucose and lipoprotein metabolism before and after the administration of sitagliptin for twelve weeks. There were significant decreases in fasting glucose levels and HbA1c levels as well as fasting TG levels and non HDL-C levels. Biomarkers of remnant lipoproteins, fasting apolipoprotein(apo) B-48 and RemL-C levels were significantly decreased by sitagliptin. Moreover, there were significant decreases in other apolipoproteins such as apoB, apoC2, C3 and apoE. Cholesterol and TG concentrations of lipoprotein fractions in the size of VLDL and LDL were significantly decreased by sitagliptin assessed by the high performance liquid chromatography(HPLC) analysis. These findings indicated that the administration of sitagliptin improved the lipid and lipoprotein profile in patients with type II diabetes mellitus, which might be due to the decrease in atherogenic remnant lipoproteins.
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
2012 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 21 Day
Last modified on
2018 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015424

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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