UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006511
Receipt No. 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 2016/04/10

* 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 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
Middle name
Last name Shinichi Oikawa
Organization Nippon Medical School Hospital
Division name Division of Diabetes, Endocrinology, and Metabolism
Zip code
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
Middle name
Last name Shinichi Oikawa
Organization Nippon Medical School Hospital
Division name Division of Diabetes, Endocrinology, and Metabolism
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku Tokyo
TEL 03-3822-2131
Homepage URL
Email shinichi@nms.ac.jp

Sponsor
Institute Glucose and Lipid metabolism conference
Institute
Department

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
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 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
2016 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.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


Contact us.