START-J: SiTAgliptin in eldeRly Trial in Japan

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Sitagliptin
* Drug: Glimepiride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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, 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin<br> | Drug: Sitagliptin<br>* Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=< <50).<br>|
| Active Comparator: Glimepiride<br> | Drug: Glimepiride<br>* Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c at 52 W |  | Baseline and 52 W | 
| Number of Participants With Hypoglycaemia |  | From baseline to 52 W | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Achieving HbA1c < 6.9 % |  | 52 W | 
| Change From Baseline in HOMA-β at 52 W | β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5] | Baseline and 52 W | 
| Change From Baseline in Insulin/Proinsulin Ratio at 52 W |  | Baseline and 52 W | 
| Change From Baseline in Body Weight at 52 W |  | Baseline and 52 W | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Sitagliptin, Glimepiride, Elderly patients, Japanese