Efficacy and Safety comparison of Sitagliptin and Glimepiride in elderly Japanese patients with type 2 diabetes

Not Applicable

• Conditions: type 2 diabetes

• Registration Number: JPRN-UMIN000004047
• Lead Sponsor: Japan Association for Diabetes Education and Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Not provided

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, GFR<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 SPIDDM) or positive anti-GAD antibody 8.Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Efficacy: HbA1c change from baseline at 52 W as efficacy 2.Safety: Incidence of hypoglycaemia from randomization to 52 W

Secondary Outcome Measures

Name	Time	Method
Comparison between two groups in the following parameters at 52W as well as 24 W as interim analysis: 1.The proportion of subjects achieving HbA1c levels <6.9% and <7.4% 2.6-point SMBG daily profile (before and 120 min after each meal) 3.Beta cell functions (fasting IRI, CPR, HOMA-B, proinsulin/insulin ratio) 4.Incidence of hypoglycaemia; as judged by Definition and evaluation of hypoglycemia 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; Hematology and biochemistry, blood pressure 9.Subanalysis according to stratum of baseline parameters: HbA1c, duration of diabetes, beta cell function