UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013218
Receipt number 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 05:40:31

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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 or person

Institute

Osaka University Graduate School of Medicine, Department of Cardiovascular Medicine

Institute

Department

Personal name



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

Value
https://center6.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