Type 2 Diabetes
Conditions
Interventions
Enrollment and assignment of patients in 4 weeks before initiation of liraglutide-therapy. Doses of liraglutide are 0.3 mg/day during first 1 week, 0.6 mg/day during next 1 week, and subsequently 0.9
HbA1c exceeds 8% at 14 weeks. Further 12 weeks-observation is needed. Change liraglutide to insulin (insulin detemir once a day) if patients'
HbA1c still exceeds 8% at 26 weeks. Doses of insulin should be adjusted based on each patient'
s fasting plasma glucose.Change liraglutide from daily administration (once a day) to alternative administration (once a day) if patient'
s HbA1c are less than 7% at 26 weeks. Further 12 weeks-observation is needed. Change insulin detemir (once a day)- therapy to insulin basal-bolus therapy (insulin detemir once a day with 3 times insu
HbA1c still exceeds 8% at 38 weeks. Further 14 weeks-observation (to 52 weeks) is needed.
Sponsors
Dokkyo Medical University Koshigaya Hospital Internal Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients age >20 years 2)Patients who are diagnosed as type 2 diabetes 3)Patients treated with diet and exercise alone, or ones with oral anti-diabetic drugs in addition to diet-and exercise-therapy 4)HbA1c of patients>=6.1%JDS (>=6.5%NGSP) 5)Patients who gave a written informed consent for participation for this study
Exclusion criteria
Exclusion criteria: 1)Patients with hypersensitivity for liraglutide 2)Patients who developed diabetic ketoacidosis, diabetic coma 3)Patients with type 1 diabetes 4)Patients with severe infection, liver dysfunction[AST>=80IU/L, ALT>=80IU/L], and renal dysfunction [serum creatinine>=1.7mg/mL] 5)Patients under artificial dialysis 6)Patients with severe heart disease (NYHA3-4) 7)Patients with oral anti-diabetic drugs except for SUs, or insulin at initiation of liraglutide therapy 8)Patients with past history of pancreatitis 9)Patients with diabetic gastroparesis or gastrointestinal disease such as inflammatory bowel disease 10)Patients in pregnancy, during lactation, or having possibility of pregnancy 11)Patients with pasthistory of medullary thyroid cancer,Patients with family history of medullary thyroid cancer,and multiple endocrine neoplasia type 2 12)Patients who was comsident to be inadequate for enrollment in this study by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c values of patients on baseline and at 14, 52 week after initiation of liraglutide-therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Fasting or postprandial plasma glucose, serum lipids, serum C-peptide, IRI,body weight, and blood pressure of patients on baseline and at 14, 38, 52 week after initiation of liraglutide-therapy 2)Change of HbA1c values, plasma glucose levels, serum C-peptide, IRI,serum lipids, body weight, blood pressure of patients on baseline and at 14, 26, 38, 52 week after initiation of liraglutide-therapy 3) Evaluation of side-effects: nausea, vomiting, diarrhea, constipation, hypoglycemic symptom, etc. | — |
Countries
Japan
Contacts
Public ContactKohzo Takebayashi
Dokkyo Medical University Koshigaya Hospital Internal Medicine
Outcome results
None listed