Japan Prospective Long Term Clinical Trial in Type 2 Diabetes Patients with Sulfonyl Urea and Sitaglipti

Not Applicable

• Conditions: Type 2 diabetes

• Registration Number: JPRN-UMIN000005415
• Lead Sponsor: Kyoto University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-09
• Study Completion: 2014-12-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

1) severe ketosis, diabetic coma or precoma 2) moderate renal dysfunction (male, serum creatinine ≥1.5 mg/dL; female, serum creatinine ≥1.3 mg/dL ) 3) severe infection , pre- or post-operation, or severe traumatic injury 4) pregnancy, child bearing potential, or nursing 5) history of hypersensitivity to sitagliptin. 6) inadequate due to other reasons by attending physician's judgments

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c value

Secondary Outcome Measures

Name	Time	Method
A) changes in value of the following datas from baseline to 12 months after treatment; fasting plasma glucose, total cholesterol, triglyceride, high density lipoprotein cholesterol, calculated low density lipoprotein cholesterol, body weight, C-peptide in the blood, proinsulin/insulin ratio, glucagon in the blood, leptin in the blood, and HOMA-beta, B) change in the dosage of sulfonylurea, C) occurrence of hypoglycemic attack, d) occurrence of adverse event.