UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000008274
Receipt number	R000009752
Scientific Title	Comparison of the effects of sitagliptin and mitiglinide/voglibose fixed-dose combination tablets on glucose metabolism in patients with uncontrolled type-2 diabetes mellitus.
Date of disclosure of the study information	2012/06/27
Last modified on	2022/08/05 15:46:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

Comparison of the effects of sitagliptin and mitiglinide/voglibose fixed-dose combination tablets on glucose metabolism in patients with uncontrolled type-2 diabetes mellitus.

Acronym

Comparison of the effects of sitagliptin and mitiglinide/voglibose fixed-dose combination tablets on glucose metabolism

Scientific Title

Comparison of the effects of sitagliptin and mitiglinide/voglibose fixed-dose combination tablets on glucose metabolism in patients with uncontrolled type-2 diabetes mellitus.

Scientific Title:Acronym

Comparison of the effects of sitagliptin and mitiglinide/voglibose fixed-dose combination tablets on glucose metabolism

Region

Japan

Condition

type-2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To clarify the difference in therapeutic effects between 100 mg of sitagliptin and mitiglinide/voglibose fixed-dose combination tablets in type-2 diabetic patients in whom 50 mg of sitagliptin has failed to produce a sufficient effect.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

SD value

Key secondary outcomes

MAGE, mean glucose level over 24 hours, frequency of glucose levels > 180 mg/dL and < 70 mg/dL, Endo-PAT measurement, incidence of adverse reactions.

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

a group in which the dose of sitagliptin is to be increased from 50 mg to 100 mg (S group)

Interventions/Control_2

a group in which sitagliptin (50 mg) is to be switched to mitiglinide/voglibose fixed-dose combination tablets (MV group)

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 treated with 50 mg of sitagliptin for at least 12 weeks, but who do not achieve the therapeutic goal HbA1c <6.5% (HbA1c upper limit: < 8.0, fluctuation range: within 0.5%).
2) Outpatients aged 20 or older.
3) Patients who have agreed in writing to participate in the study.

Key exclusion criteria

1) Patients treated with a sulfonylurea (SU), alfa-glycosidase inhibitor (alfa-GI) or insulin secretagogue (glinide).
2) Patients with diabetic ketoacidosis, diabetic coma/precoma or type-1 diabetes mellitus.
3) Patients with severe infection or serious trauma, or those operated recently or scheduled for surgery.
4) Patients with moderate or severer renal disorder (creatinine level 1.5 mg/dL (men) or 1.3 mg/dL (women)).
5) Patients with liver disorder (AST or ALT level 3 times the normal upper limit).
6) Women who are pregnant or suspected of being pregnant.
7) Women who are breastfeeding.
8) Patients with a history of hypersensitivity to an ingredient of the study drugs.
9) Other patients judged to be ineligible by the investigator.

Target sample size

Research contact person

Name of lead principal investigator

1st name Tadashi

Middle name

Last name Arao

Organization

Kyushu Rosai Hospital, Moji Medical Center

Division name

Department of Internal Medicine , Division of Diabetes, Hematology and Collagen Disease

Zip code

801-8502

Address

3-1, Higashiminatomachi, Moji-kuKitakyushu Fukuoka 801-8502,Japan

TEL

093-331-3461

Email

t-arao@med.uoeh-u.ac.jp

Public contact

Name of contact person

1st name Arao

Middle name

Last name Tadashi

Organization

Kyushu Rosai Hospital, Moji Medical Center

Division name

Department of Internal Medicine , Division of Diabetes Mellitus, Hematology and Collagen Disease

Zip code

801-8502

Address

3-1, Higashiminatomachi, Moji-kuKitakyushu Fukuoka 801-8502,Japan

TEL

093-331-3461

Homepage URL

Email

t-arao@med.uoeh-u.ac.jp

Sponsor or person

Institute

University of Occupational and Environmental Health, Japan

Institute

Department

Personal name

Funding Source

Organization

University of Occupational and Environmental Health, Japan,the First Department of Internal Medicine, School of Medicine,

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Kyushu Rosai Hospital, Moji Medical Center

Address

3-1 Higashiminatomachi, Moji-ku, Kitakyushu City, Fukuoka, Japan

Tel

093-331-3461

Email

t-arao@med.uoeh-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 27 Day

Related information

URL releasing protocol

https://www.jstage.jst.go.jp/browse/juoeh

Publication of results

Published

Result

URL related to results and publications

https://www.jstage.jst.go.jp/browse/juoeh

Number of participants that the trial has enrolled

Results

Increasing the dose of STG to 100 mg/day reduces blood glucose levels from midnight to early morning in patients with postprandial hyperglycemia who have HbA1c values of approximately 7%, FPG levels of approximately 120 mg/dL, and postprandial glucose levels >200 mg/dL. In addition, switching to MIT/VOG improves fluctuations in blood glucose levels and postprandial hyperglycemia.

Results date posted

2022 Year 08 Month 05 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Two patients switched from STG to MIT/VOG, and 3 patients switched from MIT/VOG to STG. Mean age was 66.2 years, and mean duration of disease was 22.4 years. Mean body weight was 61.5 kg, and mean body mass index was 23.0kg/m2. Complications included nerve complications (60 percent), retinopathy (20percent), and nephropathy (20 percent). The mean HbA1c value was 7.1 percent, mean fasting plasma glucose level was 126.8 mg/dL, mean fasting insulin resistance index was 6.8, mean homeostasis model assessment-insulin resistance was 2.1, and mean urine C-peptide immunoreactivity was 78.6.

Participant flow

The subjects were 5 outpatients (4 men and 1 woman; age range, 20 to 79 years) with type 2 diabetes mellitus who were being treated with STG 50 mg at the University of Occupational and Environmental Health in Japan. Their HbA1c values were >6.5percent, and they had no fluctuations in HbA1c values 16 weeks after the start of oral administration of STG 50 mg (range of HbA1c fluctuations, <0.5%).
Patients were excluded from the study if they met any of the following criteria 1) treatment with sulfonylurea drugs, arfa-GI, or glinide drugs 2) diagnosis of diabetic ketoacidosis, diabetic coma, or type 1 diabetes mellitus 3) diagnosis of serious infectious disease, underwent or were about to undergo surgery, or diagnosis of serious trauma 4) diagnosis of moderate or severe renal disease (creatinine level >1.5 mg/dL for men and >1.3 mg/dL for women) 5) diagnosis of liver disorder (aspartate aminotransferase or alanine aminotransferase levels 3 times greater than normal); and 6) pregnancy, possible pregnancy, or lactation.

Adverse events

None

Outcome measures

The MAGE was significantly lower with MIT/VOG as compared with STG. Treatment with neither drug resulted in a blood glucose level of <70 mg/dL, and the percentage of time blood glucose levels were >200 mg/dL was significantly shorter with MIT/VOG. Although there was no difference in 24-hour mean blood glucose levels or mean blood glucose between 12:00 a.m. and 7:00 a.m. and between 7:00 a.m. and 12:00 a.m., the mean blood glucose levels between 12:00 a.m. and 7:00 a.m. showed a lower trend with STG 100 mg. Moreover, maximum blood glucose levels were lower with MIT/VOG, and minimum blood glucose levels were lower with STG 100 mg. Increases in blood glucose levels after breakfast and lunch showed no difference between the 2 drugs. however, increases in blood glucose levels after dinner and mean increases in postprandial blood glucose levels were significantly lower with MIT/VOG.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 06 Month 16 Day

Date of IRB

2011 Year 10 Month 23 Day

Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date

2014 Year 01 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2012 Year 06 Month 27 Day

Last modified on

2022 Year 08 Month 05 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009752