N/A
N=150
Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02489773 ↗Enrolled (actual)
150
Serious AEs
5.3%
Results posted
Nov 2019
Primary outcome: Primary: Compare the Pearson Correlation of Glycated Albumin (GA) and Fructosamine Within All Subjects With the Performance Goal of 0.8 — 0.7056; 0.5271 Pearson correlation coefficient — p=>0.9999
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Asahi Kasei Therapeutics Corporation
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare the Pearson Correlation of Glycated Albumin (GA) and Fructosamine Within All Subjects With the Performance Goal of 0.8 |
0.7056; 0.5271 | >0.9999 |
| SECONDARY Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1 |
0.481; 0.233 | <0.0001 sig |
| SECONDARY Kendall Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval MBG in the First 3 Months in Group 1 |
0.341; 0.160 | <0.0001 sig |
Summary
To confirm that Lucica ® Glycated Albumin-L is useful for the intermediate term (preceding 2-3 weeks) monitoring of glycemic control in patients with diabetes.
Eligibility Criteria
Inclusion Criteria
Subjects may be included in the study if they meet all the following criteria:
- Male and female subjects 18 years of age and older
- Subjects with Type 1 or Type 2 diabetes (enrolled in an approximate ratio of 1:1, respectively)
- Subjects with an HbA1c value within the range of 7.5% to 12% (or higher) for Group 1 and <7.5% for Group 2
Note: The study investigator or primary physician must be planning to institute, or must be in the process of instituting, therapy to improve glycemic control for subjects in Group 1; this therapy can include oral agents, insulin, or non-insulin injectable anti-diabetic medications.
- Willingness to complete the protocol requirements, including the use of self-monitoring of blood glucose (SMBG) and attendance at all scheduled study visits; if selected for continious glucose monitoring (CGM) , a willingness to follow the additional requirements and to use only the CGM device model provided for the study
- Satisfactory completion of home SMBG measurements during the screening period of the study prior to enrollment at Visit 2
Exclusion Criteria
Subjects will be excluded from the study if they meet any of the following criteria:
- Any clinically significant disease, as determined by the investigator, that would interfere with study evaluations including but not limited to the following current or historical conditions/procedures (self-reported by the subject):
- End-stage renal disease
- Chronic kidney disease of Stage 3 or greater
- Liver cirrhosis
- Uncontrolled or untreated thyroid disease
- Any other acute or chronic conditions that, in the opinion of the investigator, may significantly influence albumin or glucose metabolism (Note: routine iron deficiencies and abnormal hemoglobin variants are not exclusions)
- History within the last 6 months of a blood transfusion
- Any other condition or factor that, in the opinion of the investigator, would complicate or compromise the study or the well-being of the subject
Data sourced from ClinicalTrials.gov (NCT02489773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.