Type 2 diabetes
Conditions
Interventions
DPP-4 inhibitor(Linagliptin) group
GLP-1 receptor agonist(Liraglutide) group
Sponsors
Kansai Electric Power Hospital
Medical Co. LTA HAKATA CLINIC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Japanese T2DM patients (2)Patients treated with 1OAD or not treated with OAD (3)HbA1c (NGSP) 6.0 - 8.0 at screening visit (for patient treated with 1OAD) 6.0 - 8.5 (for patient not treated with OAD) at screening visit (regardless of sex) (5)BMI<30kg/m2
Exclusion criteria
Exclusion criteria: (1)Patients with diabetes requiring insulin therapy (insulin intensive therapy, T1DM, etc) (2)Patients currently treated with Insulin, DPP-4inhibitor, GLP-1 receptor agonist within 4 weeks and/or treated with Pioglitazon within 12weeks (3)Patients currently treated with alpha blocker, beta blocker, selective serotonin reuptake inhibitors (4)Patients with history of cerebrovascular and cardiovascular disease (5)Patients with heart failure with NYHA I-IV (6)Patients with renal dysfunction (7)Patients with severe hepatic dysfunction (8)Patients with history of pancreatitis (9)Patients with diabetic retinopathy (proliferative retinopathy, vitreous hemorrhage and more severe condition) (10)Patients with autonomic neuropathy (11)Patients with a history of surgery of gastrointestinal tract (12)Patients with malignant tumor (13)Patients with severe infection, in the perioperative period or with serious injury (14)Excessive alcohol intake (15)Patients with hemoglobin (Hb) <13.0g/dL(male), <12.5g/dL(female) (16)Patients found ineligible as a study patient according to the discretion of the investigator or sub-investigator (17)Patients participating in other clinical studies (18)Pregnant or possibly pregnant women (19)Patients judged as inadequate to participate in present study by investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To explore the change in the following measurements during hypoglycemic (45mg/dL glucose) clamp at 2 weeks after Linagliptin/Liraglutide treatment: (1)Changes in plasma levels of glucagon (2)Its correlation with biologically intact GIP | — |
Secondary
| Measure | Time frame |
|---|---|
| To explore the change in the following measurements during hypoglycemic (45mg/dL glucose) clamp at 2weeks after Linagliptin/Liraglutide treatment: (1)ISR, ISR/Glucose (2)Pancreatic and autonomic hormonal response to hypoglycemia(Epinephrine, Norepinephrine, Cortisol, GH) | — |
Countries
Japan
Contacts
Public ContactDaisuke Yabe
Kansai Electric Power Hospital Center for Diabetes, Endocrinology and Metabolism
Outcome results
None listed