Investigation of suitable administration-time of GLP-1 receptor agonist on glycemic control in patients with type 2 diabetes: multicenter-randomized non-blind study

Not Applicable

Completed

• Conditions: Type 2 Diabetes

• Registration Number: JPRN-UMIN000004781
• Lead Sponsor: Dokkyo Medical University Koshigaya Hospital Internal Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-25
• Study Completion: 2013-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients with hypersensitivity for liraglutide 2)Patients who developed diabetic ketoacidosis, diabetic coma 3)Patients with type 1 diabetes 4)Patients with severe infection, liver dysfunction[AST>=80IU/L, ALT>=80IU/L], and renal dysfunction [serum creatinine>=1.7mg/mL] 5)Patients under artificial dialysis 6)Patients with severe heart disease (NYHA3-4) 7)Patients with oral anti-diabetic drugs except for SUs, or insulin at initiation of liraglutide therapy 8)Patients with past history of pancreatitis 9)Patients with diabetic gastroparesis or gastrointestinal disease such as inflammatory bowel disease 10)Patients in pregnancy, during lactation, or having possibility of pregnancy 11)Patients with pasthistory of medullary thyroid cancer,Patients with family history of medullary thyroid cancer,and multiple endocrine neoplasia type 2 12)Patients who was comsident to be inadequate for enrollment in this study by doctors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c values of patients on baseline and at 14, 52 week after initiation of liraglutide-therapy

Secondary Outcome Measures

Name	Time	Method
1)Fasting or postprandial plasma glucose, serum lipids, serum C-peptide, IRI,body weight, and blood pressure of patients on baseline and at 14, 38, 52 week after initiation of liraglutide-therapy 2)Change of HbA1c values, plasma glucose levels, serum C-peptide, IRI,serum lipids, body weight, blood pressure of patients on baseline and at 14, 26, 38, 52 week after initiation of liraglutide-therapy 3) Evaluation of side-effects: nausea, vomiting, diarrhea, constipation, hypoglycemic symptom, etc.