UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005681
Receipt number R000006722
Scientific Title Prospective, randomized, open-label, clinical trial comparing the effects of sitagliptin and alogliptin on postprandial glucose/lipids metabolism and endothelial function in diabetic patients
Date of disclosure of the study information 2011/06/01
Last modified on 2016/02/08 18:19:27

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Basic information

Public title

Prospective, randomized, open-label, clinical trial comparing the effects of sitagliptin and alogliptin on postprandial glucose/lipids metabolism and endothelial function in diabetic patients

Acronym

Prospective, randomized, open-label, clinical trial comparing the effects of sitagliptin and alogliptin

Scientific Title

Prospective, randomized, open-label, clinical trial comparing the effects of sitagliptin and alogliptin on postprandial glucose/lipids metabolism and endothelial function in diabetic patients

Scientific Title:Acronym

Prospective, randomized, open-label, clinical trial comparing the effects of sitagliptin and alogliptin

Region

Japan


Condition

Condition

Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of sitagliptin versus alogliptin on postprandial glucose/lipids metabolism and endothelial function in diabetic patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hemoglobin A1C levels, glycoalbumin levels, pre/postprandial blood glucose/lipids levels, and flow-mediated vasodilation in forearm
Six weeks after administration

Key secondary outcomes

Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria)
Six weeks after administration


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of sitagliptin first, then change to alogliptin

Interventions/Control_2

Administration of alogliptin first, then change to sitagliptin

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

1) diabetic patients whose HbA1c is greater than 5.8, fasting blood glucose levels greater than 110mg/dl, or postprandial glucose levels grater than 180mg/dl, despite medical therapy including life style change/medications for at least 8 weeks
2) Outpatients
3) Subjects who gave written informed consent

Key exclusion criteria

1) Allergy against sitagliptin/alogliptin
2) Type I diabetes
3) Secondary diabetes
4) Poor-controlled diabetes (HbA1c>10.0 %)
4) Secondary hypertension
5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
6) Either level of aspartate aminotransaminase or alanine aminotransferase exceed three-fold of the normal limits
7) renal insufficiency: serum creatinine>1.3 (male)>1.2(female)
8) Symptomatic (NYHA III or IV) congestive heart failure
9) Malignancies or other diseases with poor prognosis
10) Pregnant
11) Subjects whose doctor in charge do not agree to join the trial

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsunori Ikewaki

Organization

National Defense Medical College

Division name

Department of Internal Medicine I

Zip code


Address

3-2 Namiki, Tokorozawa, JAPAN 359-8513

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Makoto Ayaori

Organization

National Defense Medical College

Division name

Department of Internal Medicine I

Zip code


Address

3-2 Namiki, Tokorozawa, JAPAN 359-8513

TEL

04-2995-1597

Homepage URL


Email

ayaori@ndmc.ac.jp


Sponsor or person

Institute

National Defense Medical College

Institute

Department

Personal name



Funding Source

Organization

Foundation for Promotion of Defense Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2011 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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 05 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 05 Month 31 Day

Last modified on

2016 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006722


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name