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

Phase 3

• Conditions: type 1 diabetes

• Registration Number: JPRN-jRCTs051180138
• Lead Sponsor: Sakaguchi Kazuhiko

Brief Summary

Comparing the SD of FBG level, IDeg was noninferior to IGla-300 in SD of FBG.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-18
• Study Completion: 2019-08-31
• Results First Posted: 2020-08-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 46

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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).