Status:
COMPLETED
START-J: SiTAgliptin in eldeRly Trial in Japan
Lead Sponsor:
Japan Association for Diabetes Education and Care
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
60+ years
Phase:
NA
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 Type 2 diabetes as evaluated by HbA1c change from baseline at 52 ...
Eligibility Criteria
Inclusion
- Patients with type 2 diabetes who are oral hypoglycemic agent naive or, α-glucosidase inhibitor or biguanide 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
- 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, eGFR\<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 slowly progressive insulin dependent diabetes mellitus) or positive anti-glutamic acid decarboxylase antibody
- Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT01183104
Start Date
August 1 2010
End Date
January 1 2015
Last Update
April 14 2017
Active Locations (1)
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1
Japan Association for Diabetes Education and Care
Chiyoda-Ku, Tokyo, Japan, 102-0083