Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study

NCT02489773 | Completed Results

• 1 other identifier: CIP002
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Diabetes

Keywords

Lucica; glycated albumin; GA; fructosamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) 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

  From baseline to the first 3 months after enrollment in Group 1

Study Arms (2)

Group 1

HbA1c values ranged from 7.5% to 12% (or higher)

Group 2

HbA1c values \<7.5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Asahi Kasei Pharma Corporation: lead

Study Sites (8)

National Research Institute - Huntington Park

Los Angeles, California, United States

Location

National Research Institute-Westlake

Los Angeles, California, United States

Location

Kentucky Diabetes Endocrinology Center

Lexington, Kentucky, United States

Location

Tulane University

New Orleans, Louisiana, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, United States

Location

Texas Diabetes & Endocrinology, P.A. -Austin

Austin, Texas, United States

Location

Dallas Diabetes and Endocrine Center

Dallas, Texas, United States

Location

Capital Clinical Research Center

Olympia, Washington, United States

Location

Related Publications (2)

• Desouza CV, Rosenstock J, Kohzuma T, Fonseca VA. Glycated Albumin Correlates With Time-in-Range Better Than HbA1c or Fructosamine. J Clin Endocrinol Metab. 2023 Oct 18;108(11):e1193-e1198. doi: 10.1210/clinem/dgad298.

  PMID: 37259605 DERIVED

• 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.

  PMID: 31650161 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Takuji Kohzuma PhD
• Organization: Asahi Kasei Pharma Corporation

kouzuma.tb@om.asahi-kasei.co.jp

+81-3-3296-3617

Study Officials

• Hideji Hiraoka, M.S.

  Diagnostics Department, Asahi Kasei Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 3, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 21, 2019
• Results First Posted: November 21, 2019

Record last verified: 2019-11

Locations

US (8)