Type 2 diabetes
Conditions
Interventions
BID IDegAsp arm Insulin titration: Treat to target (FPG less than 110 mg/dl)
Insulin degludec plus liraglutide arm The liraglutide dose was titrated to and maintained at 0.9 mg/day. Insu
Sponsors
Dokkyo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 2 diabetes Patients who have received insulin therapy more than 3 months HbA1c values between 7.0 and 10.5% Body mass index (BMI) between 17.0 and 40 Patients who gave written informed consent
Exclusion criteria
Exclusion criteria: Patients who have experienced severe diabeticketosis, diabetic coma, or past history of pre-coma prior to 6 months Patients with severe infections, severe injury or perioperative state. Female patients who have pregnancy or possibilty of pregnancy, or are under lactation Patients who had past history of hypersensitivity or allergic reaction to insulin degludec, aspart or liraglutide Patients with severe liver or renal dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in HbA1c after 26 and 52 weeks of treatment. The achievement rate of HbA1c < 7.0% | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in HbA1c levels (0,12,26,52 weeks) 7 points plasma glucose (Daily profile) (0,12,26,52 weeks) Changes in body weight and BMI (0,12,26,52 weeks) Dosage of insulin and liraglutide (0,12,26,52 weeks) Frequencies of all hypoglycemic episodes Changes in serum C-peptide (0,52 weeks) CD16/TLR4 on blood monocytes (0,52 weeks) Changes in GOT/GPT (0,52 weeks) Change in coefficient of Variation of R-R intervals (0,52 weeks) Changes in urinary albumin excretion (0,52 weeks) | — |
Countries
Japan
Contacts
Public ContactKunihiro Suzuki
Dokkyo Medical University Hospital Endocrinology and Metabolism
Outcome results
None listed