Trial Outcomes & Findings for Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study (NCT NCT02489773)

NCT ID: NCT02489773

Last Updated: 2019-11-21

Results Overview

Recruitment status

COMPLETED

Target enrollment

150 participants

Primary outcome timeframe

From baseline to 6 months

Results posted on

2019-11-21

Participant Flow

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.

A total of 165 patients were screened for the study, 150 patients were enrolled.

Participant milestones

Participant milestones
Measure	HbA1c Values Ranged From ≥7.5% to 12% (or Higher) 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).	HbA1c Values <7.5% 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.
Overall Study STARTED	98	52
Overall Study COMPLETED	91	50
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	HbA1c Values Ranged From ≥7.5% to 12% (or Higher) 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).	HbA1c Values <7.5% 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.
Overall Study Lost to Follow-up	4	1
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Leave the country or the state	1	1

Baseline Characteristics

Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=98 Participants 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 n=52 Participants 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 n=150 Participants Total of all reporting groups
Age, Continuous	50.6 years STANDARD_DEVIATION 15.61 • n=5 Participants	50.3 years STANDARD_DEVIATION 15.81 • n=7 Participants	50.5 years STANDARD_DEVIATION 15.63 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	27 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	25 Participants n=7 Participants	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants	7 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=5 Participants	45 Participants n=7 Participants	121 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	80 Participants n=5 Participants	46 Participants n=7 Participants	126 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	98 participants n=5 Participants	52 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 6 months

Outcome measures

Outcome measures
Measure	HbA1c Values Ranged From ≥7.5% to 12% (or Higher) n=98 Participants 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).	HbA1c Values <7.5% n=52 Participants 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.
Compare the Pearson Correlation of Glycated Albumin (GA) and Fructosamine Within All Subjects With the Performance Goal of 0.8	0.7056 Pearson correlation coefficient	0.5271 Pearson correlation coefficient

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	HbA1c Values Ranged From ≥7.5% to 12% (or Higher) n=98 Participants 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).	HbA1c Values <7.5% 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.
Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1 Correlation coefficent between GA and MBG	0.481 spearman correlation coefficient	—
Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1 Correlation coefficent between HbA1c and MBG	0.233 spearman correlation coefficient	—

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	HbA1c Values Ranged From ≥7.5% to 12% (or Higher) n=98 Participants 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).	HbA1c Values <7.5% 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.
Kendall Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval MBG in the First 3 Months in Group 1 Correlation coefficient betwenn GA and MBG	0.341 kendall correaltion coefficient	—
Kendall Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval MBG in the First 3 Months in Group 1 Correlation coefficient betwenn HbA1c and MBG	0.160 kendall correaltion coefficient	—

Adverse Events

Group 1

Serious events: 5 serious events

Other events: 53 other events

Deaths: 0 deaths

Group 2

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Takuji Kohzuma PhD

Asahi Kasei Pharma Corporation

Phone: +81-3-3296-3617

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Group 1 n=98 participants at risk 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 n=52 participants at risk 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.
Nervous system disorders A loss of consciousness	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Nervous system disorders Paraesthesia	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Cardiac disorders Atrial fibrillation	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Musculoskeletal and connective tissue disorders Compartment syndrome	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Injury, poisoning and procedural complications Femur fracture	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Infections and infestations Sepsis	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Cardiac disorders Acute myocardial infarction	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Infections and infestations Pneumonia	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Infections and infestations Gastroenteritis	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Infections and infestations Cellulitis	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Skin and subcutaneous tissue disorders Skin ulcea	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Injury, poisoning and procedural complications Wound dehiscence	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Infections and infestations Osteomyelitis	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Hepatobiliary disorders Cholecystitis	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Infections and infestations Appendicitis	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)

Measure	Group 1 n=98 participants at risk 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 n=52 participants at risk 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.
Gastrointestinal disorders Nausea	4.1% 4/98 • Number of events 4 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Gastrointestinal disorders Abdominal distension	2.0% 2/98 • Number of events 2 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
General disorders Chest pain	0.00% 0/98 • Adverse events collected from enrolment (6 months)	3.8% 2/52 • Number of events 2 • Adverse events collected from enrolment (6 months)
General disorders Oedema peripheral	2.0% 2/98 • Number of events 2 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Infections and infestations Upper respiratory tract infection	12.2% 12/98 • Number of events 12 • Adverse events collected from enrolment (6 months)	5.8% 3/52 • Number of events 3 • Adverse events collected from enrolment (6 months)
Infections and infestations Nasopharyngitis	5.1% 5/98 • Number of events 5 • Adverse events collected from enrolment (6 months)	5.8% 3/52 • Number of events 3 • Adverse events collected from enrolment (6 months)
Infections and infestations Gastroenteritis	7.1% 7/98 • Number of events 7 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Infections and infestations Sinusitis	5.1% 5/98 • Number of events 5 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Infections and infestations Urinary tract infection	2.0% 2/98 • Number of events 2 • Adverse events collected from enrolment (6 months)	3.8% 2/52 • Number of events 2 • Adverse events collected from enrolment (6 months)
Infections and infestations Bronchitis	3.1% 3/98 • Number of events 3 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Infections and infestations Fungal infection	2.0% 2/98 • Number of events 2 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Infections and infestations Pharyngitis streptococcal	2.0% 2/98 • Number of events 2 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Metabolism and nutrition disorders Hyperglycaemia	8.2% 8/98 • Number of events 8 • Adverse events collected from enrolment (6 months)	15.4% 8/52 • Number of events 8 • Adverse events collected from enrolment (6 months)
Musculoskeletal and connective tissue disorders Back pain	4.1% 4/98 • Number of events 4 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Nervous system disorders Headache	4.1% 4/98 • Number of events 4 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Musculoskeletal and connective tissue disorders Paraesthesia	2.0% 2/98 • Number of events 2 • Adverse events collected from enrolment (6 months)	0.00% 0/52 • Adverse events collected from enrolment (6 months)
Respiratory, thoracic and mediastinal disorders Sinus congestion	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	3.8% 2/52 • Number of events 2 • Adverse events collected from enrolment (6 months)
Vascular disorders Hypertension	2.0% 2/98 • Number of events 2 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Endocrine disorders Autoimmune thyroiditis	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Endocrine disorders Hypothyroidism	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Gastrointestinal disorders Diarrhoea	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
General disorders Pyrexia	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Hepatobiliary disorders Cholecystitis	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Hepatobiliary disorders Chloelithiasis	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Infections and infestations Appendicitis	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Infections and infestations Lower respiratory tract infection	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Injury, poisoning and procedural complications Laceration	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Musculoskeletal and connective tissue disorders Bursitis	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Musculoskeletal and connective tissue disorders Trigger finger	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Musculoskeletal and connective tissue disorders Planer fasciitis	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Psychiatric disorders Anxiety	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Psychiatric disorders Attention deficit/ Hyperactivity disorder	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Psychiatric disorders Bipolar disorder	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Respiratory, thoracic and mediastinal disorders Cough	1.0% 1/98 • Number of events 1 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/98 • Adverse events collected from enrolment (6 months)	1.9% 1/52 • Number of events 1 • Adverse events collected from enrolment (6 months)