Study of impact of switching from existing long-acting insulin to insulin degludec, a new long-acting insulin, on glycemic control and frequency of hypoglycemia (Study on inpatients)

Study of impact of switching from existing long-acting insulin to insulin degludec, a new long-acting insulin, on glycemic control and frequency of hypoglycemia (Study on inpatients) - Study of glycemic control and frequency of hypoglycemia after switching to insulin degludec (Study on inpatients)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012458

Enrollment

Registered

2013-12-02

Start date

2013-12-02

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

type 2 diabetes

Interventions

Study of glycemic control and frequency of hypoglycemia after switching to insulin degludec

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have received insulin therapy including once-daily-administration of long-acting insulin for more than 12 weeks in addition to diet therapy and exercise therapy, and also fits the following requirement 1)HbA1c<=7.0% 2)Age between 20-80, regardless of sex

Exclusion criteria

Exclusion criteria: 1)Patients who take long-acting insulin twice daily 2)Patients in contraindication of degludec 3)Patients who were considered not to be appropriate for administration of degludec by their doctors. 4)Patients who take high dosage of sulfonylurea drug: 3mg or more Glimepiride a day, 5mg or more Glibenclamide a day, 80mg or more Gliclazide a day. 5)Patients who take GLP-1 receptor agonist in combination

Design outcomes

Primary

Measure	Time frame
Change of HbA1c levels after 12 weeks from baseline, achievement rate of HbA1c <7.0% and frequency of hypoglycemia in observation period	—

Secondary

Measure	Time frame
1)Percentage of time periods at which blood glucose level is 70mg/dL or lower during using CGM 2)Percentage of time periods at which blood glucose level is 180mg/dL or more during using CGM 3)Average blood glucose level, standard deviation (SD) of blood glucose and coefficient of variation (CV) during wearing CGM 4)Frequency of blood glucose level is 70mg/dL or lower at self-monitoring of blood glucose (SMBG) conducted 6 times a day within 2 weeks of switching 5)SD of blood glucose and intraindividual variability (CV%) at SMBG before breakfast 6)Change of glycoalbumin (GA) level and 1.5AG level in 24 weeks from baseline 7)Study of background factors in cases of attainment and non-attainment of HbA1c <7.0% 8)Change of insulin dosage 9)Changes of DTSQs, DTSQc 10)Changes of weight, BMI	—

Measure

Time frame

1)Percentage of time periods at which blood glucose level is 70mg/dL or lower during using CGM 2)Percentage of time periods at which blood glucose level is 180mg/dL or more during using CGM 3)Average blood glucose level, standard deviation (SD) of blood glucose and coefficient of variation (CV) during wearing CGM 4)Frequency of blood glucose level is 70mg/dL or lower at self-monitoring of blood glucose (SMBG) conducted 6 times a day within 2 weeks of switching 5)SD of blood glucose and intraindividual variability (CV%) at SMBG before breakfast 6)Change of glycoalbumin (GA) level and 1.5AG level in 24 weeks from baseline 7)Study of background factors in cases of attainment and non-attainment of HbA1c <7.0% 8)Change of insulin dosage 9)Changes of DTSQs, DTSQc 10)Changes of weight, BMI

—

Countries

Japan

Contacts

Public ContactJunpei Shikuma

Tokyo Medical University The Third Department of Internal Medicine(Department of Diabetes, Endocrinology and Metabolism)

naika3@tokyo-med.ac.jp03-3342-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026