twice-daily administration of basal insulin in type 1 diabetes
Conditions
Interventions
twice-daily administration of basal insulin is replaced to insulin degludec in type 1 diabetes
Sponsors
Juntendo University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)subjcets whose age are more than 20 years and under 80 years. (2)no restriction on gender (3)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
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, variability of the two treatments by the continuous glucose monitoring system(Medtronic), frequency and severity of hypoglycemic episodes | — |
Primary
| Measure | Time frame |
|---|---|
| Change of HbA1c level of the two treatment | — |
Countries
Japan
Contacts
Public ContactFuki Ikeda
Juntendo University Graduate School of Medicine Dept. of Metabolism and Endocrinology
Outcome results
None listed