Randomised, parallel-group trial to compare the efficacy and safety of GLP-1 analogue: liraglutide and DPP-4 inhibitor: sitagliptin as combination therapy in subjects with type 2 diabetes using sulfonylurea.

Not Applicable

• Conditions: Type 2 diabetes

• Registration Number: JPRN-UMIN000004970
• Lead Sponsor: Japan Diabetes Clinical Data Management Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-01
• Study Completion: 2012-08-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Not provided

Exclusion Criteria

1. Known hypoglycemia unawareness or recurrent major hypoglycemia. 2. Patients with proliferative retinopathy or maculopathy requiring acute treatment 3. Impaired hepatic function [GOT(AST)>80IU/L or GPT(ALT)>80IU/L], Impaired renal function (serum-creatinine; >=1.7mg/dL) 4. Patients with allergic reaction to the trial products or related products 5. Patients with known or previous malignant tumour and are strongly suspected of recurrence 6. Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant 7. The receipt of any investigational drug within 12 weeks prior to this trial 8. Previous treatment with liraglutide or sitagliptin 9. The receipt of insulin within 12 weeks prior to this trial (however, a temporary use of no more than 7 days in total within 12 weeks is permitted) 10. Current treatment or expected to start treatment with systemic corticosteroids 11. Any other condition which the attending physician feels would interfere with the trial 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
Fasting plasma glucose Percentage of patients achieving HbA1c target <6.5% or =<7.0%(JDS) Weight Beta-cell function (HOMA-beta, proinsulin/insulin ratio, proinsulin/C-peptide ratio) Bio-markers for cardiovascular effects (NT-proBNP, hsCPR) Blood pressure Rate of hypoglycaemic episodes Adverse events Patients questionnaire (PAID)