Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetes

Detailed Description

In order 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, subjects with Type 1 or Type 2 diabetes will be enrolled whose HbA1c values range from 7.5% to 12% (or higher) in Group 1 and <7.5% in Group 2 at Visit 1, and the comparison of glycated albumin (GA) and other glycemic control indices will be performed during 6 months in 8 clinical sites in US. Group 1 will consist of 90 evaluable subjects who have a change in diabetes management to improve glycemic control; this therapy can include oral agents, insulin, or noninsulin injectable anti-diabetic medications. Group 2 will consist of 40 evaluable subjects already on a stable diabetic management program, who have had no change in treatment in the last 3 months and for whom there is no plan to make a change during the study period.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States
      • National Research Institute - Huntington Park
    • Los Angeles, California, United States
      • National Research Institute-Westlake
  • Kentucky
    • Lexington, Kentucky, United States
      • Kentucky Diabetes Endocrinology Center
  • Louisiana
    • New Orleans, Louisiana, United States
      • Tulane University
  • Nebraska
    • Omaha, Nebraska, United States
      • University of Nebraska Medical Center
  • Texas
    • Austin, Texas, United States
      • Texas Diabetes & Endocrinology, P.A. -Austin
    • Dallas, Texas, United States
      • Dallas Diabetes and Endocrine Center
  • Washington
    • Olympia, Washington, United States
      • Capital Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The observational study will include a cross-section of subjects from the intended use population who are being monitored for glycemic control. Equal numbers of subjects with Type 1 or Type 2 diabetes will be enrolled whose HbA1c values range from 7.5% to 12% (or higher) in Group 1 and <7.5% in Group 2 at Visit 1. Group 1 will consist of 90 evaluable subjects who have a change in diabetes management to improve glycemic control; this therapy can include oral agents, insulin, or noninsulin injectable anti-diabetic medications. Group 2 will consist of 40 evaluable subjects already on a stable diabetic management program, who have had no change in treatment in the last 3 months and for whom there is no plan to make a change during the study period.

Description

Inclusion Criteria:

Subjects may be included in the study if they meet all the following criteria:

1. Male and female subjects 18 years of age and older
2. Subjects with Type 1 or Type 2 diabetes (enrolled in an approximate ratio of 1:1, respectively)

3. 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.

4. 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
5. 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:

1. 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):

   1. End-stage renal disease
   2. Chronic kidney disease of Stage 3 or greater
   3. Liver cirrhosis
   4. Uncontrolled or untreated thyroid disease
   5. 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)
2. History within the last 6 months of a blood transfusion
3. 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group 1; HbA1c values ranged from 7.5% to 12% (or higher)
Group 2; HbA1c values <7.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare the Pearson Correlation of Glycated Albumin (GA) and Fructosamine Within All Subjects With the Performance Goal of 0.8	From baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1	Comparing the Spearman correlation of changes in GA and MBG to the Spearman correlation of changes in HbA1c and MBG, from baseline to any matching post-baseline visit in the first 3 months in Group 1.	From baseline to the first 3 months after enrollment in Group 1
Kendall Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval MBG in the First 3 Months in Group 1	Comparing the Kendall correlation of changes in GA and MBG to the Kendall correlation of changes in HbA1c and MBG, from baseline to any matching post-baseline visit in the first 3 months in Group 1.	From baseline to the first 3 months after enrollment in Group 1

Collaborators and Investigators

• Sponsor: Asahi Kasei Pharma Corporation
• Investigators: Study Director: Hideji Hiraoka, M.S., Diagnostics Department, Asahi Kasei Pharma

Publications and helpful links

General Publications

• Desouza CV, Holcomb RG, Rosenstock J, Frias JP, Hsia SH, Klein EJ, Zhou R, Kohzuma T, Fonseca VA. Results of a Study Comparing Glycated Albumin to Other Glycemic Indices. J Clin Endocrinol Metab. 2020 Mar 1;105(3):677-87. doi: 10.1210/clinem/dgz087.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: July 2, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: GA; fructosamine; glycated albumin; Lucica
• Other Study ID Numbers: CIP002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED