<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02987348</url>
  </required_header>
  <id_info>
    <org_study_id>D5551R00010</org_study_id>
    <nct_id>NCT02987348</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes of Exenatide Versus Basal Insulin</brief_title>
  <official_title>Evaluation of the Clinical and Economic Outcomes Associated With Exenatide Versus Basal Insulin in People With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective cohort study based on Clinical Practice Research Datalink (CPRD)&#xD;
      database analysis to compare therapy effectiveness, and cost between exenatide and basal&#xD;
      insulin in patients with type 2 diabetes.&#xD;
&#xD;
      Type 2 diabetes (T2DM) is a chronic condition characterized by elevated blood sugar levels&#xD;
      (hyperglycaemia) that can result in an increased risk of a variety of conditions including&#xD;
      heart disease, strokes, kidney failure, blindness and amputation. Whilst initially patients&#xD;
      may control their blood sugar by lifestyle modification (diet and exercise), ultimately most&#xD;
      will require therapeutic intervention with regimens that increase in complexity as T2DM&#xD;
      progresses. Exenatide is a relatively recent anti-diabetic drug which is known to lead to&#xD;
      weight loss as well as improved blood glucose control. It has also been associated with&#xD;
      reduced heart attacks and strokes. In this study CPRD database will be used to compare&#xD;
      outcomes for patients prescribed exenatide compared with those prescribed insulin; a more&#xD;
      established treatment for T2DM. In particular changes from baseline in blood sugar control&#xD;
      and weight will be considered as the primary outcomes. As the choice to treat with exenatide&#xD;
      or insulin will be related to patient characteristics which may in themselves be associated&#xD;
      with the outcomes of the study we aim to match study patients on some of these key variables&#xD;
      and adjust for others in our analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives of the study To compare changes in HbA1c and weight from baseline in patients&#xD;
      initiated exenatide based-therapy regimen with those initiated insulin-based therapy regimen&#xD;
      among type 2 diabetes patients who were injectable naïve in primary care in UK. Health care&#xD;
      utilization will be calculated for each of the treatment cohorts, and compared.&#xD;
&#xD;
      Data source Patients will be selected from the Clinical Practice Research Datalink (CPRD), a&#xD;
      longitudinal, anonymized research database derived from nearly 700 primary-care practices in&#xD;
      the UK. These practices are considered representative of the UK as a whole. The primary-care&#xD;
      dataset (CPRD GOLD) comprises data on demographics, diagnoses, hospital referrals,&#xD;
      prescriptions emanating in primary care, and other aspects of patient care. Approximately 60%&#xD;
      of practices participate in a linkage scheme, by which their patient records are linked to&#xD;
      other data sources, including the Hospital Episode Statistics (HES) dataset which provides&#xD;
      data on all inpatient and outpatient contacts occurring within National Health Service&#xD;
      hospitals in England, and the Office for National Statistics (ONS) mortality dataset.&#xD;
      Diagnostic information in the CPRD primary-care dataset is recorded using the Read code&#xD;
      classification a UK primary-care practice standard. HES inpatient data are recorded using the&#xD;
      International Classification of Disease codes, 10th revision (ICD-10); ONS mortality data are&#xD;
      recorded using the ICD-10 and ICD-9 classifications.&#xD;
&#xD;
      Patient identification and Method&#xD;
&#xD;
      Patients defined by CPRD as being of acceptable research quality will be classified as having&#xD;
      type 2 diabetes if they had a Read code indicative of diabetes and at least one of the&#xD;
      following selection criteria applies:&#xD;
&#xD;
        1. more than one diagnostic record exclusively for type 2 diabetes,&#xD;
&#xD;
        2. prescriptions for two or more different classes of non-insulin glucose-lowering therapy,&#xD;
&#xD;
        3. a diagnostic code indicative of type 2 diabetes (regardless of conflicting diagnoses of&#xD;
           type 1 or nonspecific diabetes) plus a prescription for a non-insulin glucose lowering&#xD;
           therapy.&#xD;
&#xD;
      Two groups of cases will be defined as patients receiving exenatide as monotherapy or in&#xD;
      combination with one or more other oral glucose-lowering therapies based on therapy codes&#xD;
      recorded within CPRD. The groups will be:&#xD;
&#xD;
        1. exenatide once weekly formulation (Bydureon),&#xD;
&#xD;
        2. exenatide twice daily formulation (Byetta). Patients will be excluded if they had&#xD;
           received&#xD;
&#xD;
      1. prior injectable diabetes therapy 2. less than 90 days continuous exposure to the&#xD;
      exenatide therapy Control patients will be selected from the pool of type 2 diabetes patients&#xD;
      who had a prescription for basal insulin as monotherapy or in combination with one or more&#xD;
      other oral glucose-lowering therapies. The same exclusion criteria as that applied to cases&#xD;
      was applied, that is&#xD;
&#xD;
        1. prior injectable diabetes therapy&#xD;
&#xD;
        2. less than 90 days continuous exposure to basal insulin&#xD;
&#xD;
      Matching will be performed by direct matching and by propensity score matching at a ratio of&#xD;
      1:1 based on the following criteria:&#xD;
&#xD;
        1. age (±5 years)&#xD;
&#xD;
        2. gender,&#xD;
&#xD;
        3. year of index exposure (±1 year),&#xD;
&#xD;
        4. diabetes duration (±2 years),&#xD;
&#xD;
        5. BMI (±3 kg/),&#xD;
&#xD;
        6. HbA1c [±1% (±11 mmol/mol)&#xD;
&#xD;
        7. Concurrent glucose-lowering medication.&#xD;
&#xD;
      Index date is the initiation of the study drugs between January 2009 and December 2014.&#xD;
&#xD;
      Primary care and secondary contacts will be ascertained from the CPRD GOLD and HES databases&#xD;
      respectively. Admissions will be described by number, length of stay and cost. Healthcare&#xD;
      resource groups (HRGs) will be assigned to each patient spell and processed using HRG 4&#xD;
      grouper software (National Casemix Office, Winchester, UK). The allocated HRG will then&#xD;
      linked to the 2014 National Tariff adjusted for nature of the admission (elective admissions&#xD;
      versus emergency) and excess length of stay. Primary care costs were derived from the Units&#xD;
      costs of Health and Social Care 2014 Baseline characteristics of patients initiated on either&#xD;
      Bydureon/Byetta and basal insulin will be presented for all patients and for those included&#xD;
      in the direct matched and propensity score matched analyses. Differences between&#xD;
      characteristics will be tested using the t-test for continuous variables and Pearson&#xD;
      chi-square test for categorical variables.&#xD;
&#xD;
      Outcomes All patients received standard care, no interventions were given by the study&#xD;
      investigator.&#xD;
&#xD;
      The primary outcome will be HbA1c and weight change. Baseline measures will be defined as any&#xD;
      measurement between -180 days and baseline. Change will be measured from baseline to 6 months&#xD;
      and 12 - 24 months (± 90 days) for those patients remaining on their index regimen.&#xD;
&#xD;
      HbA1c change from baseline at 6 months and 12-24 months will be calculated and differences&#xD;
      between treatment groups compared. The proportion of patients for whom HbA1c falls below 7.0%&#xD;
      will also be compared.&#xD;
&#xD;
      Weight change from baseline at 6 months and 12-24 months will be calculated and differences&#xD;
      between treatment groups compared. Differences will considered as both an absolute and&#xD;
      relative change from baseline.&#xD;
&#xD;
      Two composite end points will be considered based on the proportion of patients:&#xD;
&#xD;
        1. reaching a target of HbA1c&lt;=7.0%% with weight reduction&#xD;
&#xD;
        2. reaching a target of HbA1c&lt;=7.0%% with weight reduction ≥5% The proportion of patients&#xD;
           reaching these endpoints were compared by chi-square test. Analyses will be performed&#xD;
           for all patients and those matched directly and matched by propensity score.&#xD;
&#xD;
      Secondary outcomes - Health service utilisation Rates and costs of health service contacts&#xD;
      will be calculated and compared between treatment groups using the Mann-Whitney U-test.&#xD;
      Follow up will be defined as time from index date to last prescription date + 90 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2015</start_date>
  <completion_date type="Actual">June 30, 2015</completion_date>
  <primary_completion_date type="Actual">June 30, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline in HbA1c (%)</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>Changes in HbA1c at 6 months, 12 months and 24 months after initiation of the treatment with exenatide and basal insulin will be calculated and compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in weight (kg)</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>Changes in weight at 6 months, 12 months and 24 months after initiation of the treatment with exenatide and basal insulin will be calculated and compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in composite outcomes of HbA1c&lt;=7.0% and weight reduction</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>Changes in composite outcome of HbA1c&lt;=7.0% and any weight reduction or HbA1c&lt;=7.0% and weight reduction&gt;=5% at 6 months, 12 months and 24 months after initiation of the treatment with exenatide and basal insulin will be calculated and compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health care utilization</measure>
    <time_frame>12 months</time_frame>
    <description>Costs of health service contacts after initiation of therapy with exenatide and basal insulin will be calculated and compared using the Mann-Whitney U-test.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">18000</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>exenatide once weekly</arm_group_label>
    <description>type 2 diabetes patients who were first prescribed with exenatide once weekly in the index period identified from CPRD database of UK primary care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>basal insulin_1</arm_group_label>
    <description>type 2 diabetes patients who were first prescribed with basal insulin in the index period and matched with exenatide once weekly group identified from CPRD database of UK primary care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>exenatide twice daily</arm_group_label>
    <description>type 2 diabetes patients who were first prescribed with exenatide twice daily in the index period identified from CPRD database of UK primary care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>basal insulin_2</arm_group_label>
    <description>type 2 diabetes patients who were first prescribed with basal insulin in the index period and matched with exenatide twice daily group identified from CPRD database of UK primary care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>exenatide once weekly</intervention_name>
    <description>patients received exenatide once weekly treatment under their standard care, no intervention was given by the study investigator</description>
    <arm_group_label>exenatide once weekly</arm_group_label>
    <other_name>long_acting glucagon-like peptide-1 receptor agonist</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>exenatide twice daily</intervention_name>
    <description>patients with exenatide twice daily treatment under their standard care, no intervention was given by the study investigator.</description>
    <arm_group_label>exenatide twice daily</arm_group_label>
    <other_name>short-acting glucagon-like peptide-1 receptor agonist</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>basal insulin</intervention_name>
    <description>patients with basal insulin treatment under their standard care, no intervention was given by the study investigator</description>
    <arm_group_label>basal insulin_1</arm_group_label>
    <arm_group_label>basal insulin_2</arm_group_label>
    <other_name>long-acting insulins</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This is a non-interventional study based on secondary data analysis. Patients received&#xD;
        treatment under their standard care, no intervention was given by the study investigator.&#xD;
&#xD;
        Patients will be identified and included in the study if they were defined by CPRD as being&#xD;
        of acceptable research quality and classified as having type 2 diabetes who initiated&#xD;
        exenatide or basal insulin as monotherapy or in combination with one or more other oral&#xD;
        glucose-lowering therapies between January 2009 and December 2014.&#xD;
&#xD;
        Exenatide once weekly (Bydureon) and exenatide twice daily (Byetta) are both investigated,&#xD;
        and compared with matched basal insulin cohort.&#xD;
&#xD;
        Patients will be excluded if they had received prior injectable diabetes therapy and had&#xD;
        less than 90 days continuous exposure to the study drugs.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetic patients who initiated therapy with exenatide or basal insulin between&#xD;
             2009 and 2014.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior injectable diabetes therapy&#xD;
&#xD;
          -  less than 365 days between the latter of the patient's CPRD registration date/practice&#xD;
             up-to-standard date and study index date.&#xD;
&#xD;
          -  less than 90 days continuous exposure to Exenatide or basal insulin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Craig Currie, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pharmatelligence, UK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pharmatelligence</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 3QZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=4435&amp;filename=D5551R00010_Poster_ADA2016.pdf</url>
    <description>CSR Synopsis</description>
  </link>
  <reference>
    <citation>Holden SE, Morgan CL, Qiao Q, Jenkins-Jones S, Berni ER, Currie CJ. Healthcare resource utilization and related financial costs associated with glucose lowering with either exenatide or basal insulin: A retrospective cohort study. Diabetes Obes Metab. 2017 Aug;19(8):1097-1105. doi: 10.1111/dom.12916. Epub 2017 Mar 31.</citation>
    <PMID>28218819</PMID>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>March 28, 2017</last_update_submitted>
  <last_update_submitted_qc>March 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>type 2 diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Exenatide</mesh_term>
    <mesh_term>Insulin, Long-Acting</mesh_term>
    <mesh_term>Glucagon</mesh_term>
    <mesh_term>Glucagon-Like Peptide 1</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02987348
org study id: D5551R00010
nct id: NCT02987348
lead sponsor: 
has dmc: Yes
This is a retrospective cohort study based on Clinical Practice Research Datalink (CPRD)
      database analysis to compare therapy effectiveness, and cost between exenatide and basal
      insulin in patients with type 2 diabetes.

      Type 2 diabetes (T2DM) is a chronic condition characterized by elevated blood sugar levels
      (hyperglycaemia) that can result in an increased risk of a variety of conditions including
      heart disease, strokes, kidney failure, blindness and amputation. Whilst initially patients
      may control their blood sugar by lifestyle modification (diet and exercise), ultimately most
      will require therapeutic intervention with regimens that increase in complexity as T2DM
      progresses. Exenatide is a relatively recent anti-diabetic drug which is known to lead to
      weight loss as well as improved blood glucose control. It has also been associated with
      reduced heart attacks and strokes. In this study CPRD database will be used to compare
      outcomes for patients prescribed exenatide compared with those prescribed insulin; a more
      established treatment for T2DM. In particular changes from baseline in blood sugar control
      and weight will be considered as the primary outcomes. As the choice to treat with exenatide
      or insulin will be related to patient characteristics which may in themselves be associated
      with the outcomes of the study we aim to match study patients on some of these key variables
      and adjust for others in our analysis.
Objectives of the study To compare changes in HbA1c and weight from baseline in patients
      initiated exenatide based-therapy regimen with those initiated insulin-based therapy regimen
      among type 2 diabetes patients who were injectable naïve in primary care in UK. Health care
      utilization will be calculated for each of the treatment cohorts, and compared.

      Data source Patients will be selected from the Clinical Practice Research Datalink (CPRD), a
      longitudinal, anonymized research database derived from nearly 700 primary-care practices in
      the UK. These practices are considered representative of the UK as a whole. The primary-care
      dataset (CPRD GOLD) comprises data on demographics, diagnoses, hospital referrals,
      prescriptions emanating in primary care, and other aspects of patient care. Approximately 60%
      of practices participate in a linkage scheme, by which their patient records are linked to
      other data sources, including the Hospital Episode Statistics (HES) dataset which provides
      data on all inpatient and outpatient contacts occurring within National Health Service
      hospitals in England, and the Office for National Statistics (ONS) mortality dataset.
      Diagnostic information in the CPRD primary-care dataset is recorded using the Read code
      classification a UK primary-care practice standard. HES inpatient data are recorded using the
      International Classification of Disease codes, 10th revision (ICD-10); ONS mortality data are
      recorded using the ICD-10 and ICD-9 classifications.

      Patient identification and Method

      Patients defined by CPRD as being of acceptable research quality will be classified as having
      type 2 diabetes if they had a Read code indicative of diabetes and at least one of the
      following selection criteria applies:

        1. more than one diagnostic record exclusively for type 2 diabetes,

        2. prescriptions for two or more different classes of non-insulin glucose-lowering therapy,

        3. a diagnostic code indicative of type 2 diabetes (regardless of conflicting diagnoses of
           type 1 or nonspecific diabetes) plus a prescription for a non-insulin glucose lowering
           therapy.

      Two groups of cases will be defined as patients receiving exenatide as monotherapy or in
      combination with one or more other oral glucose-lowering therapies based on therapy codes
      recorded within CPRD. The groups will be:

        1. exenatide once weekly formulation (Bydureon),

        2. exenatide twice daily formulation (Byetta). Patients will be excluded if they had
           received

      1. prior injectable diabetes therapy 2. less than 90 days continuous exposure to the
      exenatide therapy Control patients will be selected from the pool of type 2 diabetes patients
      who had a prescription for basal insulin as monotherapy or in combination with one or more
      other oral glucose-lowering therapies. The same exclusion criteria as that applied to cases
      was applied, that is

        1. prior injectable diabetes therapy

        2. less than 90 days continuous exposure to basal insulin

      Matching will be performed by direct matching and by propensity score matching at a ratio of
      1:1 based on the following criteria:

        1. age (±5 years)

        2. gender,

        3. year of index exposure (±1 year),

        4. diabetes duration (±2 years),

        5. BMI (±3 kg/),

        6. HbA1c [±1% (±11 mmol/mol)

        7. Concurrent glucose-lowering medication.

      Index date is the initiation of the study drugs between January 2009 and December 2014.

      Primary care and secondary contacts will be ascertained from the CPRD GOLD and HES databases
      respectively. Admissions will be described by number, length of stay and cost. Healthcare
      resource groups (HRGs) will be assigned to each patient spell and processed using HRG 4
      grouper software (National Casemix Office, Winchester, UK). The allocated HRG will then
      linked to the 2014 National Tariff adjusted for nature of the admission (elective admissions
      versus emergency) and excess length of stay. Primary care costs were derived from the Units
      costs of Health and Social Care 2014 Baseline characteristics of patients initiated on either
      Bydureon/Byetta and basal insulin will be presented for all patients and for those included
      in the direct matched and propensity score matched analyses. Differences between
      characteristics will be tested using the t-test for continuous variables and Pearson
      chi-square test for categorical variables.

      Outcomes All patients received standard care, no interventions were given by the study
      investigator.

      The primary outcome will be HbA1c and weight change. Baseline measures will be defined as any
      measurement between -180 days and baseline. Change will be measured from baseline to 6 months
      and 12 - 24 months (± 90 days) for those patients remaining on their index regimen.

      HbA1c change from baseline at 6 months and 12-24 months will be calculated and differences
      between treatment groups compared. The proportion of patients for whom HbA1c falls below 7.0%
      will also be compared.

      Weight change from baseline at 6 months and 12-24 months will be calculated and differences
      between treatment groups compared. Differences will considered as both an absolute and
      relative change from baseline.

      Two composite end points will be considered based on the proportion of patients:

        1. reaching a target of HbA1c<=7.0%% with weight reduction

        2. reaching a target of HbA1c<=7.0%% with weight reduction ≥5% The proportion of patients
           reaching these endpoints were compared by chi-square test. Analyses will be performed
           for all patients and those matched directly and matched by propensity score.

      Secondary outcomes - Health service utilisation Rates and costs of health service contacts
      will be calculated and compared between treatment groups using the Mann-Whitney U-test.
      Follow up will be defined as time from index date to last prescription date + 90 days.
observational model: Cohort
time perspective: Retrospective
measure: Changes from baseline in HbA1c (%)
time frame: 6, 12 and 24 months
description: Changes in HbA1c at 6 months, 12 months and 24 months after initiation of the treatment with exenatide and basal insulin will be calculated and compared.
measure: Changes from baseline in weight (kg)
time frame: 6, 12 and 24 months
description: Changes in weight at 6 months, 12 months and 24 months after initiation of the treatment with exenatide and basal insulin will be calculated and compared.
measure: Changes from baseline in composite outcomes of HbA1c<=7.0% and weight reduction
time frame: 6, 12 and 24 months
description: Changes in composite outcome of HbA1c<=7.0% and any weight reduction or HbA1c<=7.0% and weight reduction>=5% at 6 months, 12 months and 24 months after initiation of the treatment with exenatide and basal insulin will be calculated and compared.
measure: Health care utilization
time frame: 12 months
description: Costs of health service contacts after initiation of therapy with exenatide and basal insulin will be calculated and compared using the Mann-Whitney U-test.
arm group label: exenatide once weekly
description: type 2 diabetes patients who were first prescribed with exenatide once weekly in the index period identified from CPRD database of UK primary care
arm group label: basal insulin_1
description: type 2 diabetes patients who were first prescribed with basal insulin in the index period and matched with exenatide once weekly group identified from CPRD database of UK primary care
arm group label: exenatide twice daily
description: type 2 diabetes patients who were first prescribed with exenatide twice daily in the index period identified from CPRD database of UK primary care
arm group label: basal insulin_2
description: type 2 diabetes patients who were first prescribed with basal insulin in the index period and matched with exenatide twice daily group identified from CPRD database of UK primary care
intervention type: Drug
intervention name: exenatide once weekly
description: patients received exenatide once weekly treatment under their standard care, no intervention was given by the study investigator
arm group label: exenatide once weekly
other name: long_acting glucagon-like peptide-1 receptor agonist
intervention type: Drug
intervention name: exenatide twice daily
description: patients with exenatide twice daily treatment under their standard care, no intervention was given by the study investigator.
arm group label: exenatide twice daily
other name: short-acting glucagon-like peptide-1 receptor agonist
intervention type: Drug
intervention name: basal insulin
description: patients with basal insulin treatment under their standard care, no intervention was given by the study investigator
arm group label: basal insulin_1
arm group label: basal insulin_2
other name: long-acting insulins
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Craig Currie, Ph.D
role: Principal Investigator
affiliation: Pharmatelligence, UK
facility: 
country: United Kingdom
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4435&filename=D5551R00010_Poster_ADA2016.pdf
description: CSR Synopsis
citation: Holden SE, Morgan CL, Qiao Q, Jenkins-Jones S, Berni ER, Currie CJ. Healthcare resource utilization and related financial costs associated with glucose lowering with either exenatide or basal insulin: A retrospective cohort study. Diabetes Obes Metab. 2017 Aug;19(8):1097-1105. doi: 10.1111/dom.12916. Epub 2017 Mar 31.
PMID: 28218819
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Exenatide
mesh term: Insulin, Long-Acting
mesh term: Glucagon
mesh term: Glucagon-Like Peptide 1