UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008591
Receipt number R000010093
Scientific Title Linagliptin study of effects on PPG,postprandial blood glucose control
Date of disclosure of the study information 2012/08/01
Last modified on 2015/06/24 20:03:05

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Basic information

Public title

Linagliptin study of effects on PPG,postprandial blood glucose control

Acronym

Linagliptin study of effects on PPG,postprandial blood glucose control

Scientific Title

Linagliptin study of effects on PPG,postprandial blood glucose control

Scientific Title:Acronym

Linagliptin study of effects on PPG,postprandial blood glucose control

Region

Japan


Condition

Condition

Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this clinical study, we will compare the inhibitory effects of linagliptin on the postprandial blood glucose level and its beta-cell-function-improving effects (insulin secretion-improving effects) with those of a control drug, an beta-glucosidase inhibitor (voglibose) that has been used for many years as a first-choice drug at the start of drug therapy, to examine whether linagliptin has the potential to become a first-choice drug for type II diabetes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

A dietary tolerance test with a test meal will be conducted. Major evaluation items include the fasting blood glucose level early in the morning, its levels 2 hours after meals, and HbA1c at the start of administration (Week 0) and after 12 weeks.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is 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

Linagliptin treatment group(Group L)

Interventions/Control_2

Voglibose treatment group(Group B)

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.Drug na&iuml;ve patients of type 2 Diabetes (HbA1c (NGSP value) higher than 6.2 and below 9.4) in whom the target of blood glucose control specified in the 2010 diabetes treatment guidelines is not achieved despite dietary / exercise treatment including those after a 12-week or longer withdrawal of previous drug treatment for diabetes.
2.Twenty years of age or older, regardless of gender
3.Patient with good compliance
4.Written consent for participation in the study

Key exclusion criteria

1.Type I and secondary diabetes
2.Severe infectious disease, before or after surgery, and severe trauma
3.Events of myocardial infarction, angina pectoris, cerebral stroke, and cerebral infarction
4.Severe liver dysfunction (AST: 100 IU/l or higher)
5.Moderate or severer heart failure,
(NYHA/New York Heart Association stage III or severer)
6.Under treatment with diabetic drugs at the time of study initiation
7.Pregnant, lactating, and possibly pregnant women and those planning to become pregnant
8.Past medical history of hypersensitivity to investigational drugs
9.Patients with cancer
10.Patent receiving steroid therapy with inflammatory affection
11.Past medical history of abdominal operation and ileus
12.Judged as ineligible by clinical investigators

Target sample size

380


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name HIROTAKA WATADA

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Medicine, Metabolism and Endocrinology

Zip code


Address

2-1-1Hongo,Bunkyo-Ku,Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Medicine, Metabolism and Endocrinology

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Japan society of Patient Reported Outcome

Institute

Department

Personal name



Funding Source

Organization

Japan society of Patient Reported Outcome

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


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

2012 Year 08 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

2012 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 20 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

2012 Year 08 Month 01 Day

Last modified on

2015 Year 06 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010093


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name