Change in variability of glucose daily profile by switching insulin Glargine to insulin Ddegludec in patients with diabetes -prospective open-label observational trial-

Change in variability of glucose daily profile by switching insulin Glargine to insulin Ddegludec in patients with diabetes -prospective open-label observational trial- - Change in variability of glucose daily profile by switching Glargine to Degludec

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000010148

Enrollment

Registered

2013-03-07

Start date

2013-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type1 or type2 diabetes mellitus

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) patients with diabetes (type1 or type2) under treatment by intensive insulin therapy including insulin Glargine whose glycemic control range is less than 130mg/dl mean in fasting blood glucose level and, less than 180mg/dl in mean postprandial blood glucose level, 2) written informed consent

Exclusion criteria

Exclusion criteria: 1) patients with unstable diabetic retinopathy, 2) severe hepatic dysfunction, renal dysfunction, heart failure, 3) history of anaphylaxis of insulin Degludec or insulin Glargine, 4) pregnancy, 5) patients who are inadequate to enter this study due to the other reasons by physician's judgments

Design outcomes

Primary

Measure	Time frame
Variability of glucose daily profile (MAGE) using Continuous Glucose Monitoring System	—

Secondary

Measure	Time frame
1) hypo- and hyper- glycemic area of glucose daily profile using Continuous Glucose Monitoring System (AUCglucose24h, AUCglucose0-6am, AUCglucose24h of less than70mg/dl, AUCglucose0-6am of less than 70mg/dl), 2) change of insulin dose, 3) Frequency of hypoglycemia (awareness and unawareness), 4) levels of insulin antibody	—

Countries

Japan

Contacts

Public ContactHideaki Miyoshi

Hokkaido University Hospital Department of Internal Medicine II

hmiyoshi@med.hokudai.ac.jp011-706-5915

Outcome results