Type 2 Diabetes MellitusNCT00635492
CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 96 sites in 5 countries.
Trial summary
Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- exenatide and any human insulin or analog insulin(s) given in any regimen by subcutaneous injection
- Type of treatment
- Injection or infusion
- How many people
- 2,515 participants
- Where
- 96 sitesin 5 countries
- Study dates
- Jan 2008to Dec 2011
- 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 study population consisted of patients aged 18 or above, with type 2 diabetes starting any of the available initial injectable treatment options (any insulin, or exenatide BID) for the treatment of type 2 diabetes as part of routine clinical care.
Who may be able to join
- are aged 18 or above
- diagnosed with type 2 diabetes
- have had a treatment decision made within the normal course of care to initiate either insulin or exenatide for the treatment of type 2 diabetes
- have not previously been treated with either insulin or exenatide
- are not simultaneously participating in another study which includes an investigational drug or procedure at study entry
- have been fully informed and given their written consent for use of their data
- have sufficient understanding of the primary language of their country such that they will be able to complete the questionnaires.
Who cannot join
None listed.
Trial locations and contacts
96 sites in 5 countries.
96 sites in 5 countries
Germany76 sites
Research Site
Alsfeld
Research
Aschaffenburg
Research Site
Aßlar
Research Site
Augsburg
Research Site
Bad Aibling
Research Site
Bad Homburg
Research Site
Bad Mergentheim
Research Site
Bergheim
Research Site
Berlin
Research
Birkenfeld
Research Site
Bosenheim
Research Site
Bruchsal
Research Site
Dortmund
Research Site
Dresden
Research Site
Duisburg
Research Site
Eberswalde
Research Site
Eilenburg
Research Site
Eisenach
Research Site
Erfurt
Research Site
Essen
Research Site
Frankfurt
Research Site
Gebhardshain
Research Site
Gersfeld
Research Site
Giessen
Research Site
Gifhorn
Research Site
Grassau
Research Site
Groß-Gerau
Research Site
Hadmersleben
Research Site
Halle
Research Site
Hamburg
Research Site
Hammelburg
Research Site
Hennigsdorf
Research Site
Hohenmölsen
Research Site
Ismaning
Research Site
Köthen
Research Site
Kutenholz
Research Site
Langen
Research Site
Langenfeld
Research Site
Leipzig
Research Site
Lichtenfels
Research Site
Ludwigsburg
Research Site
Lüneburg
Research Site
Marburg
Research Site
Mayen
Research Site
Meissen
Research Site
Minden
Research Site
Mönchengladbach
Research Site
München
Research Site
Münster
Research Site
Nassau
Research Site
Netphen
Research Site
Oberhausen
Research Site
Pirmasens
Research Site
Recklinghausen
Research Site
Rehburg-Loccum
Research Site
Reichenbach
Research Site
Riesa
Research Site
Saarbrücken
Research Site
Saarlouis
Research Site
Schkeuditz
Research Site
Schönwalde
Research Site
Schweinfurt
Research Site
Seligenstadt
Research Site
Siegen
Research Site
Stockach
Research Site
Thale
Research Site
Übach-Palenberg
Research Site
Ueckermünde
Research Site
Villingen-Schwenningen
Research Site
Völklingen
Research Site
Warburg
Research Site
Weißenberg
Research Site
Werl
Research Site
Westfalica
Research Site
Wilhelmshaven
Research Site
Wurzen
Sweden13 sites
Research Site
Ängelholm
Research Site
Angered
Research Site
Dalby
Research Site
Falun
Research Site
Gothenburg
Research Site
Limhamn
Research Site
Luleå
Research Site
Malmö
Research Site
Skivarp
Research Site
Skövde
Research Site
Stockholm
Research Site
Vadstena
Research Site
Västervik
Greece4 sites
Research Site
Kozani
Research Site
N. Efkarpia
Research Site
Thessaloniki
Research Site
Véroia
About this study
Official title: CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy - A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associated With Treatment Changes and Outcomes Over 24 Months
Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- exenatide, any human insulin or analog insulin(s) given in any regimen by subcutaneous injection
- Keywords
- diabetes, insulin, exenatide, Byetta, Amylin, Lilly
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exenatideDrug
Also called Byetta
subcutaneous injection, 5mcg or 10mcg, twice a day
any human insulin or analog insulin(s) given in any regimen by subcutaneous injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | exenatide Receives: Drug: exenatide | |
| 2 | insulin Receives: Drug: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time.
Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study.
Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following:
Insulin:
- Addition of a new medication for the treatment of type 2 diabetes
- A change in the number of times insulin is administered per day
- Discontinuation of any insulin initiated at baseline
- Substitution of a human insulin for an analogue insulin or vice-versa.
- Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change.
Exenatide:
- Addition of a new medication for the treatment of type 2 diabetes
- Discontinuation of exenatide.
Measured: Month 24
Secondary outcomes (20)
Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Measured: Baseline
Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline
Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher.
Measured: Baseline
Older Age Associated With Treatment Choice at Baseline
Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Measured: Baseline
Disinhibited Eating Associated With Treatment Choice at Baseline
Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Measured: Baseline
Higher Random Glucose Associated With Treatment Choice at Baseline
Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Measured: 6 months prior to Baseline
Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline
Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Measured: 4 weeks prior to Baseline
Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline
Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Measured: Baseline
Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline
Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).
Measured: Baseline
Changes in HbA1c From Baseline to Month 24
Changes in HbA1c From Baseline to Month 24
Measured: Baseline, Month 24
Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24
Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24. Only patients with baseline HbA1c >= 7.0 % were included in this analysis
Measured: Month 24
Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24
Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24. Note: Only patients with baseline HbA1c >=6.5% were included in this analysis.
Measured: Month 24
Changes in Weight From Baseline to Month 24
Changes in Weight From Baseline to Month 24
Measured: Baseline, Month 24
Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months
Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months
Measured: Baseline to Month 24
Incidence of Hypoglycemia Between Baseline and 24 Months
Incidence of Hypoglycemia between Baseline and 24 Months
Measured: Baseline to Month 24
Reasons for Discontinuation of Baseline Regimen
Reasons for Discontinuation of Baseline Regimen
Measured: Baseline to Month 24
Factors Associated With Treatment Change in Insulin Cohort
Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort
Measured: Baseline to Month 24
Factors Associated With Treatment Change in Exenatide BID Cohort
Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998).
Measured: Baseline to Month 24
Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months
Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months
Measured: Baseline to Month 24
Number of Contacts With Health Care Providers Between Baseline and 24 Months
Number of contacts with Health Care Providers Between Baseline and 24 Months
Measured: Baseline to Month 24
Percentage of Patients Hospitalized Between Baseline and 24 Months
Percentage of Patients Hospitalized Between Baseline and 24 Months
Measured: Baseline to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionDec 2011
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 Type 2 Diabetes MellitusStudies 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
- Prospective
- Enrolment
- 2,515 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- James Malone, MD, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635492
- Sponsor's protocol ID
- H8O-EW-B005
- Status last verified
- Mar 2015
- First submitted
- 20 Feb 2008
- Last updated
- 9 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schultheis P, Montoya MN, Zhao Q, Archer J, Madden T, Peipert JF. Contraception and ectopic pregnancy risk: a prospective observational analysis. Am J Obstet Gynecol. 2021 Feb;224(2):228-229. doi: 10.1016/j.ajog.2020.10.013. Epub 2020 Oct 10. No abstract available.
PubMed 33049248Reaney M, Mathieu C, Ostenson CG, Matthaei S, Krarup T, Kiljanski J, Salaun-Martin C, Sapin H, Theodorakis M, Guerci B. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study. Health Qual Life Outcomes. 2013 Dec 26;11:217. doi: 10.1186/1477-7525-11-217.
PubMed 24369764
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy - A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associated With Treatment Changes and Outcomes Over 24 Months
- ClinicalTrials.gov ID
- NCT00635492
- Acronym / sponsor ID
- H8O-EW-B005
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, insulin, exenatide, Byetta, Amylin, Lilly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,515 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Posted 9 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: exenatideexenatide |
| 2 | – | Drug: any human insulin or analog insulin(s) given in any regimen by subcutaneous injectioninsulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients aged 18 or above, with type 2 diabetes starting any of the available initial injectable treatment options (any insulin, or exenatide BID) for the treatment of type 2 diabetes as part of routine clinical care.
Key inclusion criteria (7 listed)
- are aged 18 or above
- diagnosed with type 2 diabetes
- have had a treatment decision made within the normal course of care to initiate either insulin or exenatide for the treatment of type 2 diabetes
- have not previously been treated with either insulin or exenatide
- are not simultaneously participating in another study which includes an investigational drug or procedure at study entry
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| exenatideAlso: Byettasubcutaneous injection, 5mcg or 10mcg, twice a day | Drug | 1 |
| any human insulin or analog insulin(s) given in any regimen by subcutaneous injection | Drug | 2 |
Primary outcome
Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
Time frame: Month 24
The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time. Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study. Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following: Insulin: * Addition of a new medication for the treatment of type 2 diabetes * A change in the number of times insulin is administered per day * Discontinuation of any insulin initiated at baseline * Substitution of a human insulin for an analogue insulin or vice-versa. * Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change. Exenatide: * Addition of a new medication for the treatment of type 2 diabetes * Discontinuation of exenatide.
20 secondary outcomes
Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Time frame: Baseline
Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline
Time frame: Baseline
Older Age Associated With Treatment Choice at Baseline
Time frame: Baseline
Disinhibited Eating Associated With Treatment Choice at Baseline
Time frame: Baseline
Higher Random Glucose Associated With Treatment Choice at Baseline
Time frame: 6 months prior to Baseline
Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline
Time frame: 4 weeks prior to Baseline
Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline
Time frame: Baseline
Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline
Time frame: Baseline
Changes in HbA1c From Baseline to Month 24
Time frame: Baseline, Month 24
Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24
Time frame: Month 24
Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24
Time frame: Month 24
Changes in Weight From Baseline to Month 24
Time frame: Baseline, Month 24
Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months
Time frame: Baseline to Month 24
Incidence of Hypoglycemia Between Baseline and 24 Months
Time frame: Baseline to Month 24
Reasons for Discontinuation of Baseline Regimen
Time frame: Baseline to Month 24
Factors Associated With Treatment Change in Insulin Cohort
Time frame: Baseline to Month 24
Factors Associated With Treatment Change in Exenatide BID Cohort
Time frame: Baseline to Month 24
Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months
Time frame: Baseline to Month 24
Number of Contacts With Health Care Providers Between Baseline and 24 Months
Time frame: Baseline to Month 24
Percentage of Patients Hospitalized Between Baseline and 24 Months
Time frame: Baseline to Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33049248Schultheis P, Montoya MN, Zhao Q, Archer J, Madden T, Peipert JF. Contraception and ectopic pregnancy risk: a prospective observational analysis. Am J Obstet Gynecol. 2021 Feb;224(2):228-229. doi: 10.1016/j.ajog.2020.10.013. Epub 2020 Oct 10. No abstract available.
- Derived from this study: PubMed 24369764Reaney M, Mathieu C, Ostenson CG, Matthaei S, Krarup T, Kiljanski J, Salaun-Martin C, Sapin H, Theodorakis M, Guerci B. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study. Health Qual Life Outcomes. 2013 Dec 26;11:217. doi: 10.1186/1477-7525-11-217.
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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.
James Malone, MD study director
Eli Lilly and Company
96 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 96 sites in 5 countries.
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 0 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 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in Germany, Sweden, Greece, Denmark, France. 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 9 Jul 2014). 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?
Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months. (time frame: Month 24). 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 NCT00635492, 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 9 Apr 2015.