Lucica ® Glycated Albumin-L Clinical Program

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Normoglycemia and Neurological Outcome

NCT01137773

Acute, Non-traumatic Subarachnoid Hemorrhage Intraparenchymal Hemorrhage Brain Injuries

TERMINATED PHASE4

The Glycaemic Effects of Glucerna® in Critically Ill Patients.

NCT02594865

Disorder of Glucose Regulation

COMPLETED NA

A Study to Identify Biomarkers of Hypoglycaemia in Patients With Type 2 Diabetes

NCT03102801

Type 2 Diabetes Mellitus With Hypoglycemia

COMPLETED NA

Cardiometabolic Effects of Rapid Glucose Excursion

NCT04488848

Diabetes Mellitus, Experimental

UNKNOWN NA

Lactic Acidosis and Prior Metformin Treatment

NCT07300293

Type 2 Diabetes

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

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

No interventions assigned to this group

Group 2

HbA1c values \<7.5%

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No