UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006511
Receipt number R000007669
Scientific Title Effects of sitagliptin and sulfonylurea on lipid and glucose metabolism in patients with type 2 diabetes fairly or poorly controlled with oral agents including sulfonylurea : a prospective randomized, multicenter, open-label trial
Date of disclosure of the study information 2011/10/11
Last modified on 2023/10/19 11:14:32

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Basic information

Public title

Effects of sitagliptin and sulfonylurea on lipid and glucose metabolism in patients with type 2 diabetes fairly or poorly controlled with oral agents including sulfonylurea
: a prospective randomized, multicenter, open-label trial

Acronym

SLIM study

Scientific Title

Effects of sitagliptin and sulfonylurea on lipid and glucose metabolism in patients with type 2 diabetes fairly or poorly controlled with oral agents including sulfonylurea
: a prospective randomized, multicenter, open-label trial

Scientific Title:Acronym

SLIM study

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare effects of sitagliptin addition and sulfonylurea intensification on lipid and glucose metabolism in patients with type 2 diabetes fairly or poorly controlled with oral agents including sulfonylurea

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Lipid profiles(apolipoproteinB-48,six types of apolipoprotein,total cholesterol,triglyceride,HDL cholesterol,LDL cholesterol,Small dense LDL,RLP-C,LPL,campesterol,sitosterol,cholestarol,lathosterol)

Key secondary outcomes

HbA1c,fasting plasma glucose,1.5AG glycoalbumin,body weight change,the frequency of(hypoglycemia)adverse event


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

sitagliptin addition group

Interventions/Control_2

sulfonylurea intensification 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)uncontrolled type 2 diabetic patients who are taking oral agents including sulfonylurea(glymepiride at a dose of 2 mg or less per day,glibenclamide at a dose of 1.25 mg or less per day,gliclazide at a dose of 40 mg or less per day)for more than 1 month. Patients whose HbA1c ranges from 6.5% to 8.5% (JDS value)
2)Patients whose Triglyceride is between 120 mg/dL and 400 mg/dL.
3)Patients who go on diets and exercise program.
4)Patients who have been received diabetes treatment for more than 6 months.
5)over 20 years age
6)Gender is not restricted.
7)Patient understands study procedures and agrees to participate in the study by giving written informed consent prior to the study start

Key exclusion criteria

1) Patients who had diabetic ketosis, or diabetic pre-coma and coma within 6 months of the study entry.
2) Patients with severe infections, before or after operation, or with serious trauma.
3) Patients with pregnancy, possibility of pregnancy or having a breast feeding.
4) Patients with renal insufficiency (serum creatinine = and > 1.5 mg/dl)
5) Patients with serious liver damage.
6) Patients who received insulin therapy.
7) Patients who received incretin-related drugs (DPP4 inhibitor or GLP-1 receptor agonist )
8) Patients who received rapid-acting insulin secretagogues
9) Patients who administered antihyperlipidemic agent for observation period.
10) Patients who had a history of hypersensitive reaction to DPP-4 inhibitor.
11) Patients whom the attending doctor estimated to be ineligible according to the medical rationale.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Shinichi
Middle name
Last name Oikawa

Organization

Nippon Medical School Hospital

Division name

Division of Diabetes, Endocrinology, and Metabolism

Zip code

1130022

Address

1-1-5 Sendagi, Bunkyo-ku Tokyo

TEL

03-3822-2131

Email

shinichi@nms.ac.jp


Public contact

Name of contact person

1st name Shinichi
Middle name
Last name Oikawa

Organization

Fukujuji Hospital, Japan Anti-Tuberculosis Association (JATA)

Division name

Division of Diabetes

Zip code

204-8522

Address

3-1-24 Matsuyama, Kiyose, Tokyo

TEL

042-491-4111

Homepage URL


Email

shinichi@nms.ac.jp


Sponsor or person

Institute

Glucose and Lipid metabolism conference

Institute

Department

Personal name



Funding Source

Organization

The Kidney Foundation, Japan

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

Nippon Medical School

Address

1-1-5, Sendagi, Bukyoku, Tokyo

Tel

0338222131

Email

shinichi@nms.ac.jp


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

日本医科大学付属病院(東京都)、いしかわ日暮里クリニック(東京都)、板垣医院(東京都)、奥田クリニック(東京都)、加藤クリニック(東京都)、武田医院(東京都)、くまのまえ医院(東京都)、目々澤医院(東京都)、森谷医院(東京都)、斉藤医院(東京都)、吉行医院(東京都)、町立八丈病院(東京都)、中島胃腸科内科クリニック(東京都)、国際医療福祉大学(福岡県)、福岡赤十字病院(福岡県)、あげた内科クリニック(宮崎県)、田川市立病院(福岡県)、佐賀記念病院(佐賀県)、乙成内科医院(福岡県)、古賀総合病院(宮崎県)、宮崎病院(宮崎県)、大分大学(大分県)、Tsukasa Health Care Hospital(鹿児島県)、馬場内科クリニック(大分県)、友岡医院(大分県)、柏市立病院(千葉県)、南越谷健身会クリニック(埼玉県)、駅ビル医院せんげん台(埼玉県)、佐々木内科小児科クリニック(東京都)、北小岩胃腸科クリニック(東京都)、西尾久クリニック(東京都)、岡田病院(東京都)、山村クリニック(東京都)、高木病院(福岡県)


Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 11 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

No longer recruiting

Date of protocol fixation

2011 Year 03 Month 30 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 01 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry

2014 Year 07 Month 01 Day

Date trial data considered complete

2014 Year 09 Month 01 Day

Date analysis concluded

2014 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 10 Month 10 Day

Last modified on

2023 Year 10 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007669


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name