START-J: SiTAgliptin in eldeRly Trial in Japan

This study is currently recruiting participants.

Verified March 2012 by Japan Association for Diabetes Education and Care

Sponsor:

Collaborator:

Merck

Information provided by (Responsible Party):

Japan Association for Diabetes Education and Care

ClinicalTrials.gov Identifier:

NCT01183104

First received: August 16, 2010

Last updated: March 15, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 16, 2010

Last Updated Date

March 15, 2012

Start Date ^ICMJE

August 2010

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HbA1c change from baseline as efficacy and incidence of hypoglycaemia as safety [ Time Frame: From randomization to 52 W ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01183104 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Comparison between two groups in the following parameters at 52W as well as 24 W as interim analysis [ Time Frame: 24W and 52W ] [ Designated as safety issue: Yes ]

1.The proportion of subjects achieving HbA1c levels <6.9% and <7.4% 2.6-point SMBG daily profile 3.Beta cell functions 4.Incidence of hypoglycaemia 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 9.Subanalysis according to stratum of baseline parameters

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

START-J: SiTAgliptin in eldeRly Trial in Japan

Official Title ^ICMJE

Efficacy and Safety Comparison of Sitagliptin and Glimepiride in Elderly Japanese Patients With Type 2 Diabetes

Brief Summary

The purpose of this study is to compare the efficacy and the safety of sitagliptin and glimepiride in drug naïve 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. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in efficacy as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to glimepiride in safety as judged by incidence of hypoglycemia in drug naïve elderly patients with T2DM. In addition, comparison of efficacy is extended to 104W.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Drug: Sitagliptin, Glimepiride

Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; GFR 30=< <50).

Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg

Study Arm (s)

Experimental: Sitagliptin
Intervention: Drug: Sitagliptin, Glimepiride
Active Comparator: Glimepiride
Intervention: Drug: Sitagliptin, Glimepiride

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

900

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with type 2 diabetes who are OHA naive or, a-GI or BG monotherapy (to be washed out 4 weeks prior to randomization)
Signed informed consent obtained before any trial-related activities
Treatment with diet and exercise for 12 weeks and longer at screening
Age =>60 y.o.
Male and Female
HbA1c 6.9%=< <8.9%

Exclusion Criteria:

Active proliferative retinopathy or maculopathy requiring treatment
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
Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator
Recurrent hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
Previous history of severe allergy to pharmaceutical products
Systemic glucocorticoids users or potential users
Suspected type 1 diabetes (including SPIDDM) or positive anti-GAD antibody
Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yasuo Terauchi, M.D., Ph.D.

81-45-787-2639

terauchi@yokohama-cu.ac.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01183104

Other Study ID Numbers ^ICMJE

START-J, UMIN000004047

Has Data Monitoring Committee

Yes

Responsible Party

Japan Association for Diabetes Education and Care

Study Sponsor ^ICMJE

Japan Association for Diabetes Education and Care

Collaborators ^ICMJE

Merck

Investigators ^ICMJE

Principal Investigator:

Yasuo Terauchi, M.D., Ph.D.

Yokohama City University School of Medicine

Information Provided By

Japan Association for Diabetes Education and Care

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top