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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004047
Receipt No. R000004851
Scientific Title Efficacy and Safety comparison of Sitagliptin and Glimepiride in elderly Japanese patients with type 2 diabetes
Date of disclosure of the study information 2010/08/16
Last modified on 2015/02/16

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Basic information
Public title Efficacy and Safety comparison of Sitagliptin and Glimepiride in elderly Japanese patients with type 2 diabetes
Acronym START-J: SiTAgliptin in eldeRly Trial in Japan
Scientific Title Efficacy and Safety comparison of Sitagliptin and Glimepiride in elderly Japanese patients with type 2 diabetes
Scientific Title:Acronym START-J: SiTAgliptin in eldeRly Trial in Japan
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 the efficacy and the safety of sitagliptin and glimepiride in drug naive elderly patients with T2DM as evaluated by HbA1c change from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Efficacy: HbA1c change from baseline at 52 W as efficacy
2.Safety: Incidence of hypoglycaemia from randomization to 52 W
Key secondary outcomes Comparison between two groups in the following parameters at 52W as well as 24 W as interim analysis:
1.The proportion of subjects achieving HbA1c levels <6.9% and <7.4%
2.6-point SMBG daily profile (before and 120 min after each meal)
3.Beta cell functions (fasting IRI, CPR, HOMA-B, proinsulin/insulin ratio)
4.Incidence of hypoglycaemia; as judged by Definition and evaluation of hypoglycemia
5.Body weight change from baseline
6.Time to rescue therapy with the comparator drug as combination sitagliptin+glimeripirde
7.Adverse events
8.Standard laboratory tests for safety; Hematology and biochemistry, blood pressure
9.Subanalysis according to stratum of baseline parameters: HbA1c, duration of diabetes, beta cell function

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 Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; GFR 30=< <50).
Interventions/Control_2 Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with type 2 diabetes who are OHA naive or a-GI or BG monotherapy (to be washed out 4 weeks prior to randomization)
2.Signed informed consent obtained before any trial-related activities
3.Treatment with diet and exercise for 12 weeks and longer at screening
4.Age =>60 y.o.
5.Male and Female
6.HbA1c 6.9%=< <8.9%
Key exclusion criteria 1.Active proliferative retinopathy or maculopathy requiring treatment
2.Liver dysfunction (>x2 of upper normal limit), moderate or severe renal dysfunction(serum Cr>1.5mg/dL in male, Cr>1.3mg/dL in female, GFR<30), severe cardiac disease (NYHA III or IV), malignancy or uncontrolled hypertension (treated or untreated) as judged by the Investigator
3.Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator
4.Recurrent hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
5.Previous history of severe allergy to pharmaceutical products
6.Systemic glucocorticoids users or potential users
7.Suspected type 1 diabetes (including SPIDDM) or positive anti-GAD antibody
8.Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis
Target sample size 900

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Terauchi
Organization Yokohama City University School of Medicine
Division name Department of Endcrinology & Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-Ku, Yokohama City 236-0004
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Shihara
Organization Japan Association for Diabetes Education and Care
Division name secretariat
Zip code
Address 2-2-4 Koujimachi, Chiyoda-ku, Tokyo 102-0083
TEL 03-3514-1721
Homepage URL http://www.nittokyo.or.jp/
Email shihara@nittokyo.or.jp

Sponsor
Institute Japan Association for Diabetes Education and Care
Institute
Department

Funding Source
Organization Banyu pharmaceutical Co., LTD.
Organization
Division
Category of Funding Organization Profit organization
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 YES
Study ID_1 NCT01183104
Org. issuing International ID_1 Clinicaltrial.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 16 Day

Related information
URL releasing protocol http://edmsweb11.eps.co.jp/start-j/
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 06 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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
2010 Year 08 Month 16 Day
Last modified on
2015 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004851

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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