Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study

Asahi Kasei Medical

Status: Completed

Conditions: Diabetes

Study type: Observational

Funder types: Industry

Identifiers

NCT02489773

CIP002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Group 1

Description:

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

Group 2

Description:

HbA1c values \<7.5%