Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study

• Sponsor: Asahi Kasei Pharma Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02489773
• Collaborator: (none)
• Enrollment: 150
• Locations: 8
• Duration (Months): 13
• Patients Per Site: 18.8
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Group 1 HbA1c values ranged from 7.5% to 12% (or higher)
Group 2 HbA1c values <7.5%

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. 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]

   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.

2. 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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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

2. 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):

2. End-stage renal disease

3. Chronic kidney disease of Stage 3 or greater

4. Liver cirrhosis

5. Uncontrolled or untreated thyroid disease

6. 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)

7. History within the last 6 months of a blood transfusion

8. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Research Institute - Huntington Park	Los Angeles	California	United States
2	National Research Institute-Westlake	Los Angeles	California	United States
3	Kentucky Diabetes Endocrinology Center	Lexington	Kentucky	United States
4	Tulane University	New Orleans	Louisiana	United States
5	University of Nebraska Medical Center	Omaha	Nebraska	United States
6	Texas Diabetes & Endocrinology, P.A. -Austin	Austin	Texas	United States
7	Dallas Diabetes and Endocrine Center	Dallas	Texas	United States
8	Capital Clinical Research Center	Olympia	Washington	United States

Sponsors and Collaborators

• Asahi Kasei Pharma Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Asahi Kasei Pharma Corporation
• ClinicalTrials.gov Identifier: NCT02489773
• Other Study ID Numbers: CIP002
• First Posted: Jul 3, 2015
• Last Update Posted: Nov 21, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Asahi Kasei Pharma Corporation: Lucica; glycated albumin; GA; fructosamine

Study Results

Participant Flow

Recruitment Details	This was a prospective, multicenter, comparative, pivotal study of assay performance in the clinical setting. The target population for this study included up to 150 patients placed into 2 groups, each containing approximately equal numbers of patients with Type 1 or Type 2 diabetes.
Pre-assignment Detail	A total of 165 patients were screened for the study, 150 patients were enrolled.

Arm/Group Title	HbA1c Values Ranged From ≥7.5% to 12% (or Higher)	HbA1c Values <7.5%
Arm/Group Description	Group 1 consisted of at least 90 patients whose HbA1c values ranged from ≥7.5% to 12% (or higher) at screening (Visit 1) and who were prescribed a change in diabetes management to improve glycemic control (therapy could have included oral agents, insulin, or noninsulin injectable anti-diabetic medications).	Group 2 consisted of at least 40 patients with HbA1c values <7.5% at Visit 1 who were already on a stable diabetic management program, had no change in treatment in the 3 months prior to screening, and for whom no change was planned during the study period.
Period Title: Overall Study
STARTED	98	52
COMPLETED	91	50
NOT COMPLETED	7	2

Baseline Characteristics

Arm/Group Title	Group 1	Group 2	Total
Arm/Group Description	Group 1 consisted of at least 90 patients whose HbA1c values ranged from ≥7.5% to 12% (or higher) at screening (Visit 1) and who were prescribed a change in diabetes management to improve glycemic control (therapy could have included oral agents, insulin, or noninsulin injectable anti-diabetic medications).	Group 2 consisted of at least 40 patients with HbA1c values <7.5% at Visit 1 who were already on a stable diabetic management program, had no change in treatment in the 3 months prior to screening, and for whom no change was planned during the study period.	Total of all reporting groups
Overall Participants	98	52	150
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.6 (15.61)	50.3 (15.81)	50.5 (15.63)
Sex: Female, Male (Count of Participants)
Female	53 54.1%	27 51.9%	80 53.3%
Male	45 45.9%	25 48.1%	70 46.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	22 22.4%	7 13.5%	29 19.3%
Not Hispanic or Latino	76 77.6%	45 86.5%	121 80.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	5 5.1%	2 3.8%	7 4.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	13 13.3%	4 7.7%	17 11.3%
White	80 81.6%	46 88.5%	126 84%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	98 100%	52 100%	150 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HbA1c Values Ranged From ≥7.5% to 12% (or Higher)	HbA1c Values <7.5%
Arm/Group Description	Group 1 consisted of at least 90 patients whose HbA1c values ranged from ≥7.5% to 12% (or higher) at screening (Visit 1) and who were prescribed a change in diabetes management to improve glycemic control (therapy could have included oral agents, insulin, or noninsulin injectable anti-diabetic medications).	Group 2 consisted of at least 40 patients with HbA1c values <7.5% at Visit 1 who were already on a stable diabetic management program, had no change in treatment in the 3 months prior to screening, and for whom no change was planned during the study period.
Measure Participants	98	52
Number [Pearson correlation coefficient]	0.7056	0.5271

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HbA1c Values Ranged From ≥7.5% to 12% (or Higher), HbA1c Values <7.5%
	Comments
	Type of Statistical Test	Other
	Comments	Calculate the pearson correlation within whole subjects (across Group 1 and Group 2)
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	pearson correlation coefficient
	Estimated Value	0.6342
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	HbA1c Values Ranged From ≥7.5% to 12% (or Higher), HbA1c Values <7.5%
	Comments
	Type of Statistical Test	Other
	Comments	Diffenrence between Pearson correlations within whole subjects (accross Group 1 and Group 2) and PG, 0.8.
Statistical Test of Hypothesis	p-Value	>0.9999
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Difference with PG 0.8
	Estimated Value	-0.1658
	Confidence Interval	(2-Sided) 95%; -0.2204 to -0.1113
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1
Description	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.
Time Frame	From baseline to the first 3 months after enrollment in Group 1

Outcome Measure Data

Analysis Population Description

It is pre-specified to collect and report data for only participants who had a change in treatment (Group 1).

Arm/Group Title	HbA1c Values Ranged From ≥7.5% to 12% (or Higher)
Arm/Group Description	Group 1 consisted of at least 90 patients whose HbA1c values ranged from ≥7.5% to 12% (or higher) at screening (Visit 1) and who were prescribed a change in diabetes management to improve glycemic control (therapy could have included oral agents, insulin, or noninsulin injectable anti-diabetic medications).
Measure Participants	98
Correlation coefficent between GA and MBG	0.481
Correlation coefficent between HbA1c and MBG	0.233

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HbA1c Values Ranged From ≥7.5% to 12% (or Higher)
	Comments
	Type of Statistical Test	Other
	Comments	The difference in Spearman correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Difference in correlation coefficients
	Estimated Value	0.249
	Confidence Interval	(2-Sided) 95%; 0.130 to 0.364
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Kendall Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval MBG in the First 3 Months in Group 1
Description	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.
Time Frame	From baseline to the first 3 months after enrollment in Group 1

Outcome Measure Data

Analysis Population Description

It is pre-specified to collect and report data for only participants who had a change in treatment (Group 1)

Arm/Group Title	HbA1c Values Ranged From ≥7.5% to 12% (or Higher)
Arm/Group Description	Group 1 consisted of at least 90 patients whose HbA1c values ranged from ≥7.5% to 12% (or higher) at screening (Visit 1) and who were prescribed a change in diabetes management to improve glycemic control (therapy could have included oral agents, insulin, or noninsulin injectable anti-diabetic medications).
Measure Participants	98
Correlation coefficient betwenn GA and MBG	0.341
Correlation coefficient betwenn HbA1c and MBG	0.160

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HbA1c Values Ranged From ≥7.5% to 12% (or Higher)
	Comments
	Type of Statistical Test	Other
	Comments	The difference in Kendall correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Difference in correlation coefficient
	Estimated Value	0.181
	Confidence Interval	(2-Sided) 95%; 0.096 to 0.265
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse events collected from enrolment (6 months)
Arm/Group Title	Group 1		Group 2
Arm/Group Description	Group 1 consisted of at least 90 patients whose HbA1c values ranged from ≥7.5% to 12% (or higher) at screening (Visit 1) and who were prescribed a change in diabetes management to improve glycemic control (therapy could have included oral agents, insulin, or noninsulin injectable anti-diabetic medications).		Group 2 consisted of at least 40 patients with HbA1c values <7.5% at Visit 1 who were already on a stable diabetic management program, had no change in treatment in the 3 months prior to screening, and for whom no change was planned during the study period.
All Cause Mortality
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/52 (0%)
Serious Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/98 (5.1%)		3/52 (5.8%)
Cardiac disorders
Atrial fibrillation	1/98 (1%)	1	0/52 (0%)	0
Acute myocardial infarction	1/98 (1%)	1	0/52 (0%)	0
Hepatobiliary disorders
Cholecystitis	0/98 (0%)	0	1/52 (1.9%)	1
Infections and infestations
Sepsis	1/98 (1%)	1	0/52 (0%)	0
Pneumonia	1/98 (1%)	1	0/52 (0%)	0
Gastroenteritis	1/98 (1%)	1	0/52 (0%)	0
Cellulitis	1/98 (1%)	1	0/52 (0%)	0
Osteomyelitis	1/98 (1%)	1	0/52 (0%)	0
Appendicitis	0/98 (0%)	0	1/52 (1.9%)	1
Injury, poisoning and procedural complications
Femur fracture	1/98 (1%)	1	0/52 (0%)	0
Wound dehiscence	1/98 (1%)	1	0/52 (0%)	0
Metabolism and nutrition disorders
Hypoglycaemia	0/98 (0%)	0	1/52 (1.9%)	1
Musculoskeletal and connective tissue disorders
Compartment syndrome	1/98 (1%)	1	0/52 (0%)	0
Nervous system disorders
A loss of consciousness	1/98 (1%)	1	0/52 (0%)	0
Paraesthesia	1/98 (1%)	1	0/52 (0%)	0
Skin and subcutaneous tissue disorders
Skin ulcea	1/98 (1%)	1	0/52 (0%)	0
Other (Not Including Serious) Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	53/98 (54.1%)		28/52 (53.8%)
Endocrine disorders
Autoimmune thyroiditis	0/98 (0%)	0	1/52 (1.9%)	1
Hypothyroidism	0/98 (0%)	0	1/52 (1.9%)	1
Gastrointestinal disorders
Nausea	4/98 (4.1%)	4	0/52 (0%)	0
Abdominal distension	2/98 (2%)	2	0/52 (0%)	0
Diarrhoea	0/98 (0%)	0	1/52 (1.9%)	1
Gastrooesophageal reflux disease	0/98 (0%)	0	1/52 (1.9%)	1
General disorders
Chest pain	0/98 (0%)	0	2/52 (3.8%)	2
Oedema peripheral	2/98 (2%)	2	0/52 (0%)	0
Pyrexia	1/98 (1%)	1	1/52 (1.9%)	1
Hepatobiliary disorders
Cholecystitis	0/98 (0%)	0	1/52 (1.9%)	1
Chloelithiasis	0/98 (0%)	0	1/52 (1.9%)	1
Infections and infestations
Upper respiratory tract infection	12/98 (12.2%)	12	3/52 (5.8%)	3
Nasopharyngitis	5/98 (5.1%)	5	3/52 (5.8%)	3
Gastroenteritis	7/98 (7.1%)	7	0/52 (0%)	0
Sinusitis	5/98 (5.1%)	5	0/52 (0%)	0
Urinary tract infection	2/98 (2%)	2	2/52 (3.8%)	2
Bronchitis	3/98 (3.1%)	3	0/52 (0%)	0
Fungal infection	2/98 (2%)	2	0/52 (0%)	0
Pharyngitis streptococcal	2/98 (2%)	2	0/52 (0%)	0
Appendicitis	0/98 (0%)	0	1/52 (1.9%)	1
Lower respiratory tract infection	0/98 (0%)	0	1/52 (1.9%)	1
Injury, poisoning and procedural complications
Laceration	0/98 (0%)	0	1/52 (1.9%)	1
Skin abrasion	0/98 (0%)	0	1/52 (1.9%)	1
Metabolism and nutrition disorders
Hyperglycaemia	8/98 (8.2%)	8	8/52 (15.4%)	8
Hypoglycemia	0/98 (0%)	0	1/52 (1.9%)	1
Musculoskeletal and connective tissue disorders
Back pain	4/98 (4.1%)	4	1/52 (1.9%)	1
Paraesthesia	2/98 (2%)	2	0/52 (0%)	0
Bursitis	1/98 (1%)	1	1/52 (1.9%)	1
Trigger finger	1/98 (1%)	1	1/52 (1.9%)	1
Exostosis	0/98 (0%)	0	1/52 (1.9%)	1
Foot deformity	0/98 (0%)	0	1/52 (1.9%)	1
Myalgia	0/98 (0%)	0	1/52 (1.9%)	1
Planer fasciitis	0/98 (0%)	0	1/52 (1.9%)	1
Nervous system disorders
Headache	4/98 (4.1%)	4	0/52 (0%)	0
Psychiatric disorders
Anxiety	0/98 (0%)	0	1/52 (1.9%)	1
Attention deficit/ Hyperactivity disorder	0/98 (0%)	0	1/52 (1.9%)	1
Bipolar disorder	0/98 (0%)	0	1/52 (1.9%)	1
Respiratory, thoracic and mediastinal disorders
Sinus congestion	1/98 (1%)	1	2/52 (3.8%)	2
Cough	1/98 (1%)	1	1/52 (1.9%)	1
Wheezing	0/98 (0%)	0	1/52 (1.9%)	1
Skin and subcutaneous tissue disorders
Erythema	0/98 (0%)	0	1/52 (1.9%)	1
Vascular disorders
Hypertension	2/98 (2%)	2	1/52 (1.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

After (a) the date multicenter publication is made, (b) Sponsor notifies Institution that there will be no multicenter publication, or (c) 12 months after the date the Study has been closed at all participating sites, whichever date comes first, Institution may itself publish the results of its data from the Study.