START-J: SiTAgliptin in eldeRly Trial in Japan

Japan Association for Diabetes Education and Care

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Drug: Sitagliptin; Drug: Glimepiride

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01183104

START-J

UMIN000004047 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 305 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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)
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%

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, eGFR<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 slowly progressive insulin dependent diabetes mellitus) or positive anti-glutamic acid decarboxylase antibody
8. Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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305 participants in 2 patient groups

Sitagliptin

Experimental group

Treatment:

Drug: Sitagliptin

Glimepiride

Active Comparator group

Treatment:

Drug: Glimepiride