Study on the effects of sitagliptin on glycemic control in newly treated or uncontrolled patients with type 2 diabetes mellitus

Not Applicable

• Conditions: Type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000019154
• Lead Sponsor: Kanto Antidiabetics Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-06-01
• Study Start: 2015-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who met any of the following criteria are to be excluded: 1) Patients with a history of severe ketosis, diabetic coma or pre-coma within the past 6 months 2) Patients who are about to have or who have undergone an operation or who have severe infections or serious injury 3) Pregnant, possibly pregnant, or lactating women 4) Patients with moderate kidney dysfunction (serum creatinine >or= 1.5 mg/dL for men, >or= 1.3 mg/dL for women ) 5) Patients who are being treated with insulin 6) Patients who are being treated with rapid acting insulin secretagogues 7) Patients with a history of hypersensitivity to ingredients of the study drug 8) Patients who are considered not eligible for the study by the attending doctor due to medical reasons

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c after 3 months of treatment from baseline

Secondary Outcome Measures

Name	Time	Method
1) The following parameters at baseline, and 1, 3, and 12 months after treatment - Percentage of patients with normal HbA1c level - Percentage of patients with normal fasting blood glucose level 2) Change in the following parameters after 1,3,and 12 months of treatment from baseline - HbA1c (except the value after 3 months) - Fasting blood glucose - HOMA-beta - lipids (LDL-C, TG, and HDL-C) 3) Safety throughout the study period - Incidence of adverse reactions / incidence of hypoglycemia 4) Exploratory analysis Subanalyses stratifying patients by factors including response to sitagliptin, complications, concomitant drugs, and a history of diabetes.