Efficacy and safety of Liraglutide versus high-dose metformin as an initial treatment of type 2 diabetes; open label, randomized controlled trial

Efficacy and safety of Liraglutide versus high-dose metformin as an initial treatment of type 2 diabetes; open label, randomized controlled trial - Keio study for INitial treatment of type 2 Diabetes with Liraglutide versus Metformin: KIND-LM study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004243

Enrollment

110

Registered

2010-10-01

Start date

2010-10-01

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 monotherapy 24-week treatment of high-dose metformin monotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes mellitus. 2. Informed consent obtained. 3. Age >=20 years, <75 years 4. Patients on diet/exercise therapy with or without OAD* monotherapy or combination therapy for no less than 3 months. (*OAD: alpha-glucosidase inhibitor or biganide) 5. Patients diagnosed as type 2 diabetes mellitus in ten years. 6. HbA1c >=6.5%, <9.0%(JDS). 7. BMI >=23.5kg/m2. 8. Patients able to come to hospital/clinic every bi-week.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
HbA1c level after 24 weeks of treatment	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactYoshifumi Saisho

Keio University , School of Mecidicine Department of Internal Medicine

ysaisho@keio.jp03-5363-3797

Outcome results

None listed

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