type 2 diabetes
Conditions
Interventions
Insulin glargine is replaced to insulin degludec with same insulin dose under the treatment of basal-bolus insulin therapy in type 2 diabetes.
Sponsors
Juntendo University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hospitalized patients with type 2 diabetes with Basal-Bolus therapy using insulin glargine (1)subjcets whose fasting blood glucose are controlled to less than 140 mg/dl (2)subjcets whose age are more than 20 years and under 80 years. (3)no restriction on gender (4)written informed consent was obtained from all subjects after they had been provided with sufficient information about the study.
Exclusion criteria
Exclusion criteria: 1.Patients with past medical history of hypersensitivity to Degludec. 2.Patients with serious liver,renal,pituitary and adrenal insufficiency. 3.Patients with diarrhea, vomiting and other gastrointestinal problems. 4.Patients with starvation state or unstable appetite. 5.Patients with serious diabetic complications including proliferative retinopathy. 6.Patients who are pregnant, hope to be pregnant, or are in lactation period. 7.Judged as ineligible by clinical investigators 8.Patients with type 1 diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of blood glucose variability of the two treatments (insulin degludec as basal insulin vs insulin glargin) by the Continuous Glucose Monitoring System (CGMS®, Medtronic MiniMed, Inc.) | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference between treatments in following parameters: fasting plasma glucose (FPG), variability (standard deviation) and intra individual variability of 7-point capillary blood glucose profile value measured by SMBG, frequency and severity of hypoglycemic episodes (confirmed by blood glucose < 70 mg/dl) . | — |
Countries
Japan
Contacts
Public ContactMegumi Hada
Juntendo University Graduate School of Medicine Dept. of Metabolism and Endocrinology
Outcome results
None listed