Type 2 diabetes
Conditions
Interventions
Insulin degludec arm Starting dose 0.1U/Kg/Day Once daily before breakfast Duration: 24 weeks Insulin titration: Treat to target (FPG less than 110 mg/dl)
Insulin glargine arm Starting dose 0.
Sponsors
Dokkyo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes Patients with insulin naive Patients who have received oral anti-diabetic drugs more than 3 months HbA1c values between 7.0 and 10.4% Body mass index (BMI) less than 40.0 Patients who gave written informed consent
Exclusion criteria
Exclusion criteria: Patients who have experienced severe diabetic ketosis, diabetic coma, or past history of pre-coma prior to 6 months 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 or glargine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in HbA1c after 24 weeks of treatment. Standard deviation (SD) of fasting plasma glucose between 8- and 12-week or 20- and 24-week after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequencies of all hypoglycemic episodes Frequencies of nocturnal hypoglycemic episodes during 0:01 and 5:59 AM Plasma 1, 5 anhydro-D-glucitol 7 points plasma glucose (Daily profile) Assessment of QOL evaluated by DTR-QOL Dosage of insulin Changes in body weight Urinary 8 iso-prostane | — |
Countries
Japan
Contacts
Public ContactKunihiro Suzuki
Dokkyo Medical University Hospital Endocrinology and Metabolism
Outcome results
None listed