Effects of Insulin Degludec and Insulin Glargine U300 on glucose variability in Individuals with Type 1 Diabetes

JRCT ID: jRCTs051180138

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: type 1 diabetes
• Date of first enrollment: 08/06/2018
• Target sample size: 46
• Study type: Interventional
• Intervention(s): Individuals found to satisfy the study criteria will be randomly assigned to the IGlar U300 (first period)/IDeg (second period) and the IDeg (first period)/IGlar U300 (second period) groups by a centralized allocation process. In the IGlar U300/IDeg group, the basal insulin will be switched after 4 weeks from IGlar U300 to IDeg. In the IDeg/IGlar U300 group, the basal insulin will be switched after 4 weeks from IDeg to IGlar U300. The last week of each treatment period constitutes the data collection phase. They will also be equipped with an CGM device by medical staff on a visit midway through each treatment period, and the device will be removed by the subjects after 2 weeks for collection of data for the final week.

Outcome(s)

• Primary Outcome: The primary end point of the study is the day-to-day variability of FPG level as evaluated by the SD of the plasma glucose concentration determined by SMBG before breakfast during the last week of each 4-week treatment period.
• Secondary Outcome: Secondary end points include (1) the coefficient of variance for the plasma glucose level determined by SMBG before breakfast during the last week of each 4-week treatment period; (2) the intraday glycemic variability calculated from the seven daily measurements of plasma glucose by SMBG or from FGM data during the last week of each treatment period; (3) the frequency of hypoglycemic events; (4) the duration of hypoglycemia determined by FGM; and (5) the administered basal and bolus insulin dose (the mean for the last week of each treatment period).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) individuals with type 1 diabetes
(2) aged at least 20 years
(3) serum C-peptide immunoreactivity is <0.2 ng/mL (as confirmed at least twice)
(4) treatment for at least 1 year with basal-bolus insulin injections, with the basal insulin and a rapid-acting insulin analog or regular insulin as the bolus insulin
(5) the ability to perform self-monitoring of blood glucose (SMBG)
(6) the ability to perform CGM
(7) individuals who have get a concent

Exclude criteria

(1) a glycated hemoglobin (HbA1c) level of 9.0% or higher
(2) rejection of SMBG or FGM
(3) use of medications that affect glucose metabolism (such as beta-blockers, corticosteroids, and monoamine oxidase inhibitors)
(4) a history of myocardial infarction, angina, coronary bypass surgery, or heart failure within the previous 6 months
(5) severe hypertension (systolic blood pressure of at least 180 mmHg or diastolic blood pressure of at least 100 mmHg)
(6) severe liver dysfunction (serum aspartate aminotransferase or alanine aminotransferase levels of at least 2.5 times the upper limit of normal)
(7) severe renal impairment (serum creatinine concentration of at least 2.0 mg/dL)
(8) frequently recurring severe hypoglycemia or hospitalization because of serious hypoglycemia or diabetic ketoacidosis within the previous year
(9) proliferative diabetic retinopathy with a high risk of hemorrhage
(10) existing or possible pregnancy or breastfeeding or no use of an adequate contraceptive method
(11) a diagnosis of cancer
(12) a complicating psychiatric disorder
(13) alcoholism or other drug addiction
(14) declaration by an investigator that the individual is otherwise inappropriate for the study

Related Information

• Primary Sponsor: Sakaguchi Kazuhiko
• Source(s) of Monetary Support: Novo Nordisk Pharma Ltd
• Secondary ID(s): 000029630