UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017566
Receipt number R000020337
Scientific Title Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2015/05/18
Last modified on 2015/05/14 16:47:51

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Basic information

Public title

Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus

Acronym

Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus

Scientific Title

Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus

Scientific Title:Acronym

Comparison of sitagliptin and glimepiride in patients with type 2 diabetes mellitus

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of sitagliptin and glimepiride regarding clinical efficacy and safety

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

HbA1c, body weight, hypoglycemia

Key secondary outcomes

glycoalbumin, 1, 5-anhydroglucitol, blood pressure, lipids, insulin, proinsulin, adiponectin, leptin, CRP, bone metabolic markers, durability, safety


Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

sitagliptin

Interventions/Control_2

glimepiride

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

Patients with type 2 diabetes inadequately controlled with following therapies (HbA1c 6.9~10.4%)
1) diet and exercise therapy
2) treated with glinides or biguanides or pioglitazone monotherapy
3) treated with glinides and biguanides or pioglitazone (dual therapy)

Key exclusion criteria

1) kidney dysfunction (serum creatinine > 1.5 mg/dl in men, >1.3 mg/dl in women, or nephrotic syndrome)
2) heart failure, stroke
3) liver dysfunction (serum AST and/or ALT >100mU/ml or liver cirrhosis)
4) respiratory failure (needing oxygen therapy)
5) pregnant women
6) treated with sulfonyureas or alpha-glucosidase inhibitors
7) ketosis, diabetic coma, type 1 diabetes mellitus, severe infection
8) dementia
9) other inadequate patients



Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shoichiro Nagasaka

Organization

Jichi Medical University

Division name

Division of Endocrinology and Metabolism

Zip code


Address

Yakushiji 3311-1, Shimotsuke, Tochigi

TEL

81-285-58-7355

Email

sngsk@jichi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shoichiro Nagasaka

Organization

Jichi Medical University

Division name

Division of Endocrinology and Metabolism

Zip code


Address

Yakushiji 3311-1, Shimotsuke, Tochigi

TEL

81-285-58-7355

Homepage URL


Email

sngsk@jichi.ac.jp


Sponsor or person

Institute

Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

The Waksman Foundation of Japan INC

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

自治医科大学附属病院(栃木県)、あいそ内科(東京都)、やたがい内科クリニック(栃木県)、小山イーストクリニック(栃木県)、長崎病院(栃木県)、川井クリニック(茨城県)、いたばし糖尿病内科皮フ科クリニック(茨城県)、済生会宇都宮病院(栃木県)


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 18 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

2010 Year 05 Month 25 Day

Date of IRB


Anticipated trial start date

2010 Year 05 Month 25 Day

Last follow-up date

2014 Year 12 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

2015 Year 05 Month 14 Day

Last modified on

2015 Year 05 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020337


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name