Efficacy and safety of Liraglutide versus high-dose metformin as an initial treatment of type 2 diabetes; open label, randomized controlled trial
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000004243
- Lead Sponsor
- Keio University , School of Mecidicine, Department of Internal Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 110
Not provided
1.Type 1 diabetes mellitus 2.No informed consent 3.Patients with allergic reaction 4.Pregnant, intention of becoming pregnant 5.Patients with history of lactic acidosis 6.Impaired hepatic function (AST>80IU/L or ALT>80IU/L), Impaired renal function [serum-creatinine; >=1.3mg/dL(male), >=1.2mg/dL(female)] 7.Patients with pre-proliferative retinopathy, or proliferative retinopathy 8.Patients with the gastrointestinal disorder, such as inflam-matory bowel disease and diabetic gastroparesis 9.Patients with history of pancreatitis 10.Patients with a personal history of medullary thyroid carcinoma (MTC) or those from families with known familial MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). 11.Non compliance 12.Patients taking systemic corticosteroids 13.Previous liraglutide treatment 14.Any other condition which the attending physician feels would interfere with the study participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c level after 24 weeks of treatment
- Secondary Outcome Measures
Name Time Method Percentage of patients achieving HbA1c target <6.5% or 7.0%(JDS) Fasting plasma glucose Body weight Rate of hypoglycaemic episodes Beta-cell function (HOMA-beta, proinsulin/insulin ratio) Bio-markers for cardiovascular effects (PAI-1, hsCPR, BNP) Bio-markers for oxidative stress (8-OH-dG, 8-isoprostane) Patients QOL questionnaire