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.

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. - 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004970

Enrollment

152

Registered

2011-02-01

Start date

2010-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

24-week treatment of liraglutide in combination with SU 24-week treatment of sitagliptin in combination with SU

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes mellitus (Age >=18 years, <80 years). 2. Patients able to come to hospital/clinic every bi-week. 3. Patients on monotherapy of sulfonylurea* or combination therapy of sulfonylurea with other one or two OAD for no less than 8 weeks. (*sulfonylurea: glimepilide 2~6mg, glibenclamide 2.5~10mg, gliclazide 80~160mg) 4. HbA1c >=6.5%, <=9.0%(JDS). 5. BMI <=35kg/m2. 6. Informed consent obtained

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
HbA1c level after 24 weeks of treatment	—

Secondary

Measure	Time frame
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)	—

Countries

Japan

Contacts

Public ContactHiroki Yokoyama

Jiyugaoka Medical Clinic Internal Medicine

dryokoyama@yokoyamanaika.sakura.ne.jp0155-20-5011

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026