Type 2 DiabetesNCT02917057
Subanalyses of Elderly Type 2 Diabetes Patients or Type 2 Diabetes Patients With Renal Impairment
An observational study of Type 2 Diabetes, run by AstraZeneca at 1 site in United States.
Trial summary
Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves glucose control with low risk of hypoglycemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- exenatide once weekly and basal insulin
- How many people
- 6,024 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2015to 1 Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population was drawn from an Optum's Electronic Health Records (EHR) database. Injectable-naive type 2 diabetic patients who initiated therapy with either Exenatide once-weekly or basal insulin from January 2012 to January 2015, with follow-up through March 2015 were identified. The baseline period was defined as the 183 days (6-months) prior to date of study drug initiation (index date). Patients with Type 2 diabetes were identified using structured diagnosis fields and International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) codes. Initiations of Exenatide once-weekly or basal insulin were identified in the EHR data capturing prescribed medications using National Drug Codes (NDC).
Who may be able to join
- At least 18 years old;
- had received care documented in EHR (including at least one out-patient provider visit) for a minimum of 6-months prior index date;
- had at least one diagnosis of Type 2 diabetes (ICD-9-CM: 250.X0 or 250.X2) prior to and including the date of the study drug initiation, with no prior diagnosis of type1 diabetes (ICD-9-CM: 250.X1 or 250.X3), or gestational diabetes within the 6-months prior to index date;
- No evidence of prior injectable antidiabetic treatment, specifically no dispensing of a GLP-1-RA or any insulin during the 6-months baseline period prior to study drug initiation
Who cannot join
- Prior diagnosis of type 1 diabetes (ICD-9-CM: 250.X1 or 250.X3), or gestational diabetes within the 6-months prior to index date;
- Prior dispensing of a GLP-1RA or any insulin
- Missing data on renal function defined by eGFR or age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cohort Study of the Benefits of Bydureon in Customary Clinical Care in the United States - Additional Analyses
Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as necessary for other glucagon-like peptide-1 agonists, and appears to have other advantages, such as reducing insulin resistance, reducing weight, and improving blood pressure and lipid profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes in customary clinical care in patients with mild and moderate renal impairment and in elderly patients are unknown.
The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative to basal insulin initiated as first-ever injectable therapeutic regimens among elderly patients and patients with renal impairment. Patients who initiated treatment with Bydureon or basal insulin between July 2011 and March 2015 will be recruited into the study cohorts from Optum's database of electronic health records. The two treatment cohorts will be matched by propensity score method. Changes in HbA1c, weight, markers for renal function (estimated glomerular filtration rate (eGFR), serum creatinine, and albumin/creatinine ratio (ACR)), and incidences of gastrointestinal symptoms and hypoglycaemia are investigated for patients with different eGFR categories and with different ages.
Read the detailed description
Background: In January 2012, the US Food and Drug Administration approved a once-weekly form of exenatide, Bydureon, for the treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as necessary for other glucagon-like peptide-1 agonists (GLP-1RAs), and appears to have other advantages, such as reducing insulin resistance, reducing weight, and improving blood pressure and lipid profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes in patients with renal impairment or who are elderly is unknown.
Aims: The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative to basal insulin initiated as first-ever injectable therapeutic regimens among elderly patients and patients with renal impairment.
The specific study objectives are as follows:
- To quantify the effectiveness of Bydureon initiation relative to initiation of basal insulin, on improving:
- Glycated hemoglobin (HbA1c)
- Weight (body mass index (BMI))
- HbA1c simultaneous to reduction in weight
- Blood pressure and lipid profiles
- To examine the tolerability of Bydureon initiation relative to initiation basal insulin, on the occurrence of :
- Hypoglycemia
- Gastrointestinal symptoms (nausea, vomiting, diarrhea, and constipation)
- Change in the markers for renal function (estimated glomerular filtration rate (eGFR), serum creatinine, and albumin/creatinine ratio (ACR), and the stability of liver function test (AST, ALT) and standard blood counts (WBC, RBC, HCT, Hgb, PLT)
- To examine these measures of effectiveness and tolerability within potentially vulnerable subgroups of Bydureon and basal insulin initiators:
- T2D patients with renal impairment
- Elderly T2D patients Study Population and Design: This retrospective cohort study will use Optum's EHR data from July 2011 through March 2015 and identify injectable-naive T2D patients who initiated either Bydureon or basal insulin during the accrual period, January 2012 and January 2015. Injectable-naive T2D patients will be indetified. Propensity score methods will be used to match Bydureon initiators with basal insulin initiators.
Subgroup Comparisons: Within the EHR data, serum creatinine values will be used to calculate the eGFR using an equation developed by the Chronic Kidney Disease (CKD) Epidemiology (EPI) Collaboration, called the CKD-EPI Equation.
Renal Impairment: Patients will be stratified by eGFR ranges in baseline indicative of the renal impairment, as follows:
- Normal, eGFR ≥ 90.00 mL/min/1.73m2
- Mild impairment, 60.00 < eGFR < 89.99 mL/min/1.73m2
- Moderate and Severe impairment, eGFR < 59.99 mL/min/1.73m2
Elderly T2D Patients: Elderly subgroups will be defined as 65+ years of age. Patients will be stratified by age on index date, as follows:
- < 65 years
- 65 to 74 years
- 75+ years Outcomes and Analysis: To measure the effectiveness of Bydureon relative to basal insulin are changes in HbA1c and body weight, as well as changes in HbA1c and simultaneous reduction in weight. Changes in BMI, lipid profiles, and blood pressure will be assessed. These variables are part of the clinical and laboratory data in the EHR. Each outcome will be evaluated for completeness, multiply imputed, and reported across standardized time intervals. HbA1c, weight and BMI will be summarized in baseline and quarterly (3-month intervals) in the first year following drug initiation. Lipid measurements and blood pressure will be summarized in baseline and bi-annually (6-month intervals) in the first year following drug initiation.
To assess drug tolerability, incidence of hypoglycemia, and gastrointestinal symptoms (nausea, vomiting, diarrhea, and constipation) will be calculated. These outcomes will be ascertained using an ICD-9 algorithm applied to the structured fields and by extracting mentions of hypoglycemia using a natural language processing (NLP) algorithm developed by Optum and applied to the free text clinical notes available in the data. In addition the stability of renal function evaluated by change in eGFR, or albumin/creatinine ratio (ACR); the change in serum hepatic enzymes [aspartate aminotransferase (AST), alanine aminotransferase (ALT)], and hematologic measures [red blood cells counts (RBC), white blood cell counts (WBC), platelets (PLT), hemoglobin (Hgb) and hematocrit (Hct) will be evaluated. Each of these laboratory values will be evaluated for completeness, multiply imputed, and reported across standardized time intervals. eGFR and ACR are summarized in baseline and quarterly (3-month intervals) in the first year following drug initiation. Hepatic enzymes and hematologic measures are summarized in baseline and semi-annually (6-month intervals) in the first year following drug initiation.
- Conditions
- Type 2 Diabetes
- Being tested
- exenatide once weekly, basal insulin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exenatide once weeklyDrug
Exenatide treatment in customary clinical care in the USA
basal insulinDrug
basal insulin tretament in the customary clinical care in USA
| Study group | Role | What they receive |
|---|---|---|
| Exenatide once weekly initiators | Type 2 diabetes patients who initiated exenatide once weekly treatment during the index period Receives: Drug: exenatide once weekly | |
| Basal Insulin initiator cohort | Type 2 diabetes patients who initiated basal insulin treatment in the index period Receives: Drug: basal insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in HbA1c (%)
To evaluate changes in HbA1c (%) from baseline after initiation of therapy with exenatide once-weekly in patients with different renal functions or age classes, as referred to basal insulin initiators of the same subgroups.
Measured: one year post-index
Changes from baseline in weight (kg)
To evaluate changes in weight (kg) from baseline after initiation of therapy with exenatide once-weekly in patients with different renal functions or age classes, as referred to basal insulin initiators of the same subgroups.
Measured: one year post-index
Secondary outcomes (4)
Changes from baseline in eGFR
Changes in eGFR after initiation of therapy with exenatide once-weekly in patients with different renal functions or age classes, as referred to basal insulin initiators of the same subgroups.
Measured: one year post-index
Frequency of Hypoglycemia
Frequency of episodes of hypoglycaemia after initiation of therapy with exenatide once-weekly in patients with different renal functions or age classes, as referred to basal insulin initiators of the same subgroups.
Measured: one year post-index
Frequency of Nausea
Frequency of episodes of nausea after initiation of therapy with exenatide once-weekly in patients with different renal functions or age classes, as referred to basal insulin initiators of the same subgroups.
Measured: one year post-index
Frequency of Vomiting
Frequency of episodes of vomiting after initiation of therapy with exenatide once-weekly in patients with different renal functions or age classes, as referred to basal insulin initiators of the same subgroups.
Measured: one year post-index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start1 Aug 2015
- Primary completion1 Aug 2015
- Study completion1 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anita M Loughlin, Ph.D, Principal investigator, Optum, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917057
- Sponsor's protocol ID
- D5551R00011
- Status last verified
- Mar 2018
- First submitted
- 8 Sep 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Loughlin AM, Qiao Q, Nunes AP, Ohman P, Ezzy S, Yochum L, Clifford CR, Gately R, Dore DD, Seeger JD. Effectiveness and tolerability of therapy with exenatide once weekly vs basal insulin among injectable-drug-naive elderly or renal impaired patients with type 2 diabetes in the United States. Diabetes Obes Metab. 2018 Apr;20(4):898-909. doi: 10.1111/dom.13175. Epub 2018 Jan 3.
PubMed 29193561
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of the Benefits of Bydureon in Customary Clinical Care in the United States - Additional Analyses
- ClinicalTrials.gov ID
- NCT02917057
- Acronym / sponsor ID
- D5551R00011
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,024 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 1 Aug 2015 (actual)
- Study completion
- 1 Aug 2015 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as necessary for other glucagon-like peptide-1 agonists, and appears to have other advantages, such as reducing insulin resistance, reducing weight, and improving blood pressure and lipid profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes in customary clinical care in patients with mild and moderate renal impairment and in elderly patients are unknown.
The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative to basal insulin initiated as first-ever injectable therapeutic regimens among elderly patients and patients with renal impairment. Patients who initiated treatment with Bydureon or basal insulin between July 2011 and March 2015 will be recruited into the study cohorts from Optum's database of electronic health records. The two treatment cohorts will be matched by propensity score method. Changes in HbA1c, weight, markers for renal function (estimated glomerular filtration rate (eGFR), serum creatinine, and albumin/creatinine ratio (ACR)), and incidences of gastrointestinal symptoms and hypoglycaemia are investigated for patients with different eGFR categories and with different ages.
Detailed description
Background: In January 2012, the US Food and Drug Administration approved a once-weekly form of exenatide, Bydureon, for the treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as necessary for other glucagon-like peptide-1 agonists (GLP-1RAs), and appears to have other advantages, such as reducing insulin resistance, reducing weight, and improving blood pressure and lipid profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes in patients with renal impairment or who are elderly is unknown.
Aims: The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative to basal insulin initiated as first-ever injectable therapeutic regimens among elderly patients and patients with renal impairment.
The specific study objectives are as follows:
- To quantify the effectiveness of Bydureon initiation relative to initiation of basal insulin, on improving:
- Glycated hemoglobin (HbA1c)
- Weight (body mass index (BMI))
- HbA1c simultaneous to reduction in weight
- Blood pressure and lipid profiles
- To examine the tolerability of Bydureon initiation relative to initiation basal insulin, on the occurrence of :
- Hypoglycemia
- Gastrointestinal symptoms (nausea, vomiting, diarrhea, and constipation)
- Change in the markers for renal function (estimated glomerular filtration rate (eGFR), serum creatinine, and albumin/creatinine ratio (ACR), and the stability of liver function test (AST, ALT) and standard blood counts (WBC, RBC, HCT, Hgb, PLT)
- To examine these measures of effectiveness and tolerability within potentially vulnerable subgroups of Bydureon and basal insulin initiators:
- T2D patients with renal impairment
- Elderly T2D patients Study Population and Design: This retrospective cohort study will use Optum's EHR data from July 2011 through March 2015 and identify injectable-naive T2D patients who initiated either Bydureon or basal insulin during the accrual period, January 2012 and January 2015. Injectable-naive T2D patients will be indetified. Propensity score methods will be used to match Bydureon initiators with basal insulin initiators.
Subgroup Comparisons: Within the EHR data, serum creatinine values will be used to calculate the eGFR using an equation developed by the Chronic Kidney Disease (CKD) Epidemiology (EPI) Collaboration, called the CKD-EPI Equation.
Renal Impairment: Patients will be stratified by eGFR ranges in baseline indicative of the renal impairment, as follows:
- Normal, eGFR ≥ 90.00 mL/min/1.73m2
- Mild impairment, 60.00 < eGFR < 89.99 mL/min/1.73m2
- Moderate and Severe impairment, eGFR < 59.99 mL/min/1.73m2
Elderly T2D Patients: Elderly subgroups will be defined as 65+ years of age. Patients will be stratified by age on index date, as follows:
- < 65 years
- 65 to 74 years
- 75+ years Outcomes and Analysis: To measure the effectiveness of Bydureon relative to basal insulin are changes in HbA1c and body weight, as well as changes in HbA1c and simultaneous reduction in weight. Changes in BMI, lipid profiles, and blood pressure will be assessed. These variables are part of the clinical and laboratory data in the EHR. Each outcome will be evaluated for completeness, multiply imputed, and reported across standardized time intervals. HbA1c, weight and BMI will be summarized in baseline and quarterly (3-month intervals) in the first year following drug initiation. Lipid measurements and blood pressure will be summarized in baseline and bi-annually (6-month intervals) in the first year following drug initiation.
To assess drug tolerability, incidence of hypoglycemia, and gastrointestinal symptoms (nausea, vomiting, diarrhea, and constipation) will be calculated. These outcomes will be ascertained using an ICD-9 algorithm applied to the structured fields and by extracting mentions of hypoglycemia using a natural language processing (NLP) algorithm developed by Optum and applied to the free text clinical notes available in the data. In addition the stability of renal function evaluated by change in eGFR, or albumin/creatinine ratio (ACR); the change in serum hepatic enzymes [aspartate aminotransferase (AST), alanine aminotransferase (ALT)], and hematologic measures [red blood cells counts (RBC), white blood cell counts (WBC), platelets (PLT), hemoglobin (Hgb) and hematocrit (Hct) will be evaluated. Each of these laboratory values will be evaluated for completeness, multiply imputed, and reported across standardized time intervals. eGFR and ACR are summarized in baseline and quarterly (3-month intervals) in the first year following drug initiation. Hepatic enzymes and hematologic measures are summarized in baseline and semi-annually (6-month intervals) in the first year following drug initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide once weekly initiators | – | Drug: exenatide once weeklyType 2 diabetes patients who initiated exenatide once weekly treatment during the index period |
| Basal Insulin initiator cohort | – | Drug: basal insulinType 2 diabetes patients who initiated basal insulin treatment in the index period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population was drawn from an Optum's Electronic Health Records (EHR) database. Injectable-naive type 2 diabetic patients who initiated therapy with either Exenatide once-weekly or basal insulin from January 2012 to January 2015, with follow-up through March 2015 were identified. The baseline period was defined as the 183 days (6-months) prior to date of study drug initiation (index date). Patients with Type 2 diabetes were identified using structured diagnosis fields and International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) codes. Initiations of Exenatide once-weekly or basal insulin were identified in the EHR data capturing prescribed medications using National Drug Codes (NDC).
Key inclusion criteria (4 listed)
- At least 18 years old;
- had received care documented in EHR (including at least one out-patient provider visit) for a minimum of 6-months prior index date;
- had at least one diagnosis of Type 2 diabetes (ICD-9-CM: 250.X0 or 250.X2) prior to and including the date of the study drug initiation, with no prior diagnosis of type1 diabetes (ICD-9-CM: 250.X1 or 250.X3), or gestational diabetes within the 6-months prior to index date;
- No evidence of prior injectable antidiabetic treatment, specifically no dispensing of a GLP-1-RA or any insulin during the 6-months baseline period prior to study drug initiation
Key exclusion criteria (3 listed)
- Prior diagnosis of type 1 diabetes (ICD-9-CM: 250.X1 or 250.X3), or gestational diabetes within the 6-months prior to index date;
- Prior dispensing of a GLP-1RA or any insulin
- Missing data on renal function defined by eGFR or age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exenatide once weeklyExenatide treatment in customary clinical care in the USA | Drug | Exenatide once weekly initiators |
| basal insulinbasal insulin tretament in the customary clinical care in USA | Drug | Basal Insulin initiator cohort |
Primary outcome
Changes from baseline in HbA1c (%)
Time frame: one year post-index
To evaluate changes in HbA1c (%) from baseline after initiation of therapy with exenatide once-weekly in patients with different renal functions or age classes, as referred to basal insulin initiators of the same subgroups.
Changes from baseline in weight (kg)
Time frame: one year post-index
To evaluate changes in weight (kg) from baseline after initiation of therapy with exenatide once-weekly in patients with different renal functions or age classes, as referred to basal insulin initiators of the same subgroups.
4 secondary outcomes
Changes from baseline in eGFR
Time frame: one year post-index
Frequency of Hypoglycemia
Time frame: one year post-index
Frequency of Nausea
Time frame: one year post-index
Frequency of Vomiting
Time frame: one year post-index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Background: PubMed 29193561Loughlin AM, Qiao Q, Nunes AP, Ohman P, Ezzy S, Yochum L, Clifford CR, Gately R, Dore DD, Seeger JD. Effectiveness and tolerability of therapy with exenatide once weekly vs basal insulin among injectable-drug-naive elderly or renal impaired patients with type 2 diabetes in the United States. Diabetes Obes Metab. 2018 Apr;20(4):898-909. doi: 10.1111/dom.13175. Epub 2018 Jan 3.
- CSR SynopsisLink provided by the sponsor.
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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.
Anita M Loughlin, Ph.D principal investigator
Optum, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by AstraZeneca at 1 site 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 4 inclusion and 3 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes from baseline in HbA1c (%) (time frame: one year post-index). The study lists 2 primary outcomes in all. 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 NCT02917057, which also lists 1 linked publication.
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 29 Mar 2018.