Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study

Completed

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT02489773

Run by

Asahi Kasei Therapeutics Corporation

People needed

150

Starts

2015-06-01

Expected to finish

2016-07-01

Last updated by the study team

2019-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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