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START-J: SiTAgliptin in eldeRly Trial in Japan

NCT01183104 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2017-04-14

Study results available
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Summary

The purpose of this study is to compare the efficacy and the safety of sitagliptin and glimepiride in drug naïve elderly patients with Type 2 diabetes 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 104 W.

Conditions

Interventions

DRUG

Sitagliptin

Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=\< \<50).

DRUG

Glimepiride

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

Sponsors & Collaborators

Principal Investigators

  • Yasuo Terauchi, M.D., Ph.D. · Yokohama City University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Japan

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01183104 on ClinicalTrials.gov