DiabetesNCT02489773
Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study
An observational study of Diabetes, run by Asahi Kasei Therapeutics Corporation at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- How many people
- 150 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2015to Jul 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The observational study will include a cross-section of subjects from the intended use population who are being monitored for glycemic control. Equal numbers of 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. 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Texas Diabetes & Endocrinology, P.A. -Austin
Austin, Texas
Dallas Diabetes and Endocrine Center
Dallas, Texas
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky
National Research Institute - Huntington Park
Los Angeles, California
National Research Institute-Westlake
Los Angeles, California
Tulane University
New Orleans, Louisiana
Capital Clinical Research Center
Olympia, Washington
University of Nebraska Medical Center
Omaha, Nebraska
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Keywords
- Lucica, glycated albumin, GA, fructosamine
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | HbA1c values ranged from 7.5% to 12% (or higher) | |
| Group 2 | HbA1c values <7.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the Pearson Correlation of Glycated Albumin (GA) and Fructosamine Within All Subjects With the Performance Goal of 0.8
Measured: From baseline to 6 months
Secondary outcomes (2)
Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months 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.
Measured: From baseline to the first 3 months after enrollment in Group 1
Kendall Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval MBG in the First 3 Months 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.
Measured: From baseline to the first 3 months after enrollment in Group 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asahi Kasei Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hideji Hiraoka, M.S., Study director, Diagnostics Department, Asahi Kasei Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489773
- Sponsor's protocol ID
- CIP002
- Status last verified
- Nov 2019
- First submitted
- 15 Jun 2015
- Last updated
- 21 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Desouza CV, Rosenstock J, Kohzuma T, Fonseca VA. Glycated Albumin Correlates With Time-in-Range Better Than HbA1c or Fructosamine. J Clin Endocrinol Metab. 2023 Oct 18;108(11):e1193-e1198. doi: 10.1210/clinem/dgad298.
PubMed 37259605Desouza CV, Holcomb RG, Rosenstock J, Frias JP, Hsia SH, Klein EJ, Zhou R, Kohzuma T, Fonseca VA. Results of a Study Comparing Glycated Albumin to Other Glycemic Indices. J Clin Endocrinol Metab. 2020 Mar 1;105(3):677-87. doi: 10.1210/clinem/dgz087.
PubMed 31650161
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study
- ClinicalTrials.gov ID
- NCT02489773
- Acronym / sponsor ID
- CIP002
- Conditions
- Diabetes
- Keywords
- Lucica, glycated albumin, GA, fructosamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Asahi Kasei Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Posted 21 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –HbA1c values ranged from 7.5% to 12% (or higher) |
| Group 2 | – | –HbA1c values <7.5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The observational study will include a cross-section of subjects from the intended use population who are being monitored for glycemic control. Equal numbers of 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. 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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):
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1
Time frame: From baseline to the first 3 months after enrollment in Group 1
Kendall Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval MBG in the First 3 Months in Group 1
Time frame: From baseline to the first 3 months after enrollment in Group 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37259605Desouza CV, Rosenstock J, Kohzuma T, Fonseca VA. Glycated Albumin Correlates With Time-in-Range Better Than HbA1c or Fructosamine. J Clin Endocrinol Metab. 2023 Oct 18;108(11):e1193-e1198. doi: 10.1210/clinem/dgad298.
- Derived from this study: PubMed 31650161Desouza CV, Holcomb RG, Rosenstock J, Frias JP, Hsia SH, Klein EJ, Zhou R, Kohzuma T, Fonseca VA. Results of a Study Comparing Glycated Albumin to Other Glycemic Indices. J Clin Endocrinol Metab. 2020 Mar 1;105(3):677-87. doi: 10.1210/clinem/dgz087.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hideji Hiraoka, M.S. study director
Diagnostics Department, Asahi Kasei Pharma
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Asahi Kasei Therapeutics Corporation at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02489773, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.