Type 2 Diabetes MellitusNCT01060059
Exenatide and Basal Insulins Use in the Real Setting: an Observational Study in Patients With Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 50 sites in Italy.
Trial summary
Although the efficacy and safety profile of exenatide has been well established, few data exist on the real world results of exenatide treatment in specific populations and clinical settings. 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 basal insulin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 888 participants
- Where
- 50 sitesItaly
- Study dates
- Apr 2010to May 2012
- 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 targeted population consists of adult patients with type 2 diabetes mellitus treated in outpatient setting by specialists.
Who may be able to join
- Are inadequately controlled with single or multiple OHA as evidenced by an HbA1c > 7.0%
- Have presented during the routine course of care and, together with their physician, have decided to initiate treatment with either exenatide twice daily or conventional insulin therapy with basal insulin (insulin glargine, detemir, protaminated insulin lispro, protaminated human insulin) added to the existing treatment with OHA
- Have not been treated with GLP-1 receptor agonist for more than 7 consecutive days within 3 months before entering the study
- Have not been treated with insulins for more than 7 consecutive days within last 3 months or more than 3 months in the course of the disease
- 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
Who cannot join
None listed.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
Italy50 sites
Research site
Acquaviva delle Fonti
Research site
Anzio
Research site
Bassano del Grappa
Research site
Bologna
Research site
Brindisi
Research site
Cagliari
Research site
Campi Salentina
Research site
Casarano
Research site
Caserta
Research site
Cesena
Research site
Chieri
Research site
Cisternino
Research site
Copertino
Research site
Cremona
Research site
Distretto Vittoria
Research site
Fermo
Research site
Ferrara
Research site
Fidenza
Research site
Florence
Research site
Forlì
Research site
Genova
Research site
Germaneto
Research site
Lecce
Research site
Livorno
Research site
Lucca
Research site
Manfredonia (Le)
Research site
Mariano Comense
Research site
Messina
Research site
Milan
Research site
Monza
Research site
Naples
Research site
Novara
Research site
Olbia
Research site
Palermo
Research site
Palmi
Research site
Parma
Research site
Pavia
Research site
Pisa
Research site
Potenza
Research site
Rimini
Research site
Roma
Research site
Rossano Scalo
Research site
Salerno
Research site
San Giovanni Rotondo
Research site
Schio
Research site
Sesto San Giovanni
Research site
Siena
Research site
Treviso
Research site
Trieste
Research site
Varese
About this study
Official title: EBIRIOS - Exenatide and Basal Insulins Use in the Real Setting: an Italian Observational Study in Patients With Type 2 Diabetes and Secondary Failure of Oral Antihyperglycemic Treatment
Although the efficacy and safety profile of exenatide has been well established, few data exist on the real world results of exenatide treatment in specific populations and clinical settings. This study is intended to fill this gap through observing and collecting prospective data from a population of Italian patients initiating treatment with either exenatide or basal insulin formulations after failure to achieve glycemic control with oral antihyperglycemic agents (OHA).
Observational studies represent noninterventional research; therefore, this study does not involve randomization of patients to particular comparator arms or therapies. The term "noninterventional" means that the healthcare providers decisions regarding the proper treatment and care of the patient are made in the course of normal clinical practice. Patients enrolled in this study are enrolling for the collection of their data on observations made during normal clinical practice.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- exenatide, basal insulin
- Keywords
- diabetes; exenatide; Byetta; basal insulin; Amylin; Lilly
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
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
basal insulinDrug
subcutaneous injection, dosing according to physician's clinical judgment
| Study group | Role | What they receive |
|---|---|---|
| exenatide | The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Receives: Drug: exenatide | |
| basal insulin | The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. Receives: Drug: basal insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.
Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.
Measured: Baseline, Month 12
Secondary outcomes (22)
Changes in HbA1c From Baseline to Month 12
Changes in HbA1c from Baseline to Month 12
Measured: Baseline, Month 12
Changes in Fasting Blood Glucose From Baseline to Month 12
Changes in Fasting Blood Glucose From Baseline to Month 12
Measured: Baseline, Month 12
Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12
Percentage of Patients with HbA1c Reduction from Baseline >= 1.0% at Month 12
Measured: Baseline, Month 12
Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12
Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12
Measured: Month 12
Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12
Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12
Measured: Month 12
Changes in Weight From Baseline to Month 12
Changes in Weight From Baseline to Month 12
Measured: Baseline, Month 12
Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12
Percentage of Patients Achieving a Weight Decrease >=3% between Baseline and Month 12
Measured: Baseline, Month 12
Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12
Percentage of Patients Achieving a Weight Decrease >=5% between Baseline and Month 12
Measured: Baseline, Month 12
Changes in Fasting Total Cholesterol Between Baseline and Month 12
Changes in Fasting Total Cholesterol Between Baseline and Month 12
Measured: Baseline, Month 12
Changes in Fasting HDL Between Baseline and Month 12
Changes in Fasting HDL Between Baseline and Month 12
Measured: Baseline, Month 12
Changes in Fasting LDL Between Baseline and Month 12
Changes in Fasting LDL Between Baseline and Month 12
Measured: Baseline, Month 12
Changes in Fasting Triglycerides Between Baseline and Month 12
Changes in Fasting Triglycerides Between Baseline and Month 12
Measured: Baseline, Month 12
Changes in Diastolic Blood Pressure Between Baseline and Month 12
Changes in Diastolic Blood Pressure Between Baseline and Month 12
Measured: Baseline, Month 12
Changes in Systolic Blood Pressure Between Baseline and Month 12
Changes in Systolic Blood Pressure Between Baseline and Month 12
Measured: Baseline, Month 12
Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12
Percentage of patients with Hypoglycemia Episodes Between Baseline and Month 12.
All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected.
Measured: Baseline to Month 12
Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline
Number of patients per arm who were evaluated in 3 factors at baseline (gender, presence of medical conditions, and previous gastrointestinal symptoms) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor.
Measured: baseline
Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline
Factor of 1% higher baseline HbA1c (from most recent HbA1c) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. HbA1c was measured as a percent of normal (%).
Measured: baseline
Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline
The Factor of longer duration of diabetes at baseline (diagnosed 1 year longer) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Duration of diabetes was measured in years since the date of diabetes diagnosis.
Measured: baseline
Factor of Older Age Associated With Treatment Choice at Baseline
Older age (1 year older) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Age was measured in years.
Measured: baseline
Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Factor of higher body mass index (BMI) (1 kilogram per meter squared (kg/m^2) higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. BMI measured as kg/m^2.
Measured: baseline
Factor of Greater Height Associated With Treatment Choice at Baseline
Factor of greater height (1 centimeter higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Height was measured in centimeters (cm) .
Measured: baseline
Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline
Factors of higher creatinine: 1 milligram per deciliter higher (mg/dL) and higher fasting lipids (HDL cholesterol: 1 mg/dL higher; total cholesterol: 1 mg/dL higher; triglycerides: 1 mg/dL higher) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Creatinine and fasting lipids were measured in milligrams per deciliter (mg/dL).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2012
- Study completionMay 2012
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.
- 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
- 888 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
- NCT01060059
- Sponsor's protocol ID
- H8O-IT-B014
- Status last verified
- Mar 2015
- First submitted
- 26 Jan 2010
- Last updated
- 9 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- EBIRIOS - Exenatide and Basal Insulins Use in the Real Setting: an Italian Observational Study in Patients With Type 2 Diabetes and Secondary Failure of Oral Antihyperglycemic Treatment
- ClinicalTrials.gov ID
- NCT01060059
- Acronym / sponsor ID
- H8O-IT-B014
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes; exenatide; Byetta; basal insulin; Amylin; Lilly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 888 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Apr 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Posted 16 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although the efficacy and safety profile of exenatide has been well established, few data exist on the real world results of exenatide treatment in specific populations and clinical settings. This study is intended to fill this gap through observing and collecting prospective data from a population of Italian patients initiating treatment with either exenatide or basal insulin formulations after failure to achieve glycemic control with oral antihyperglycemic agents (OHA).
Observational studies represent noninterventional research; therefore, this study does not involve randomization of patients to particular comparator arms or therapies. The term "noninterventional" means that the healthcare providers decisions regarding the proper treatment and care of the patient are made in the course of normal clinical practice. Patients enrolled in this study are enrolling for the collection of their data on observations made during normal clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exenatide | – | Drug: exenatideThe targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. |
| basal insulin | – | Drug: basal insulinThe targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The targeted population consists of adult patients with type 2 diabetes mellitus treated in outpatient setting by specialists.
Key inclusion criteria (6 listed)
- Are inadequately controlled with single or multiple OHA as evidenced by an HbA1c > 7.0%
- Have presented during the routine course of care and, together with their physician, have decided to initiate treatment with either exenatide twice daily or conventional insulin therapy with basal insulin (insulin glargine, detemir, protaminated insulin lispro, protaminated human insulin) added to the existing treatment with OHA
- Have not been treated with GLP-1 receptor agonist for more than 7 consecutive days within 3 months before entering the study
- Have not been treated with insulins for more than 7 consecutive days within last 3 months or more than 3 months in the course of the disease
- 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 | exenatide |
| basal insulinsubcutaneous injection, dosing according to physician's clinical judgment | Drug | basal insulin |
Primary outcome
Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.
Time frame: Baseline, Month 12
Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.
22 secondary outcomes
Changes in HbA1c From Baseline to Month 12
Time frame: Baseline, Month 12
Changes in Fasting Blood Glucose From Baseline to Month 12
Time frame: Baseline, Month 12
Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12
Time frame: Baseline, Month 12
Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12
Time frame: Month 12
Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12
Time frame: Month 12
Changes in Weight From Baseline to Month 12
Time frame: Baseline, Month 12
Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12
Time frame: Baseline, Month 12
Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12
Time frame: Baseline, Month 12
Changes in Fasting Total Cholesterol Between Baseline and Month 12
Time frame: Baseline, Month 12
Changes in Fasting HDL Between Baseline and Month 12
Time frame: Baseline, Month 12
Changes in Fasting LDL Between Baseline and Month 12
Time frame: Baseline, Month 12
Changes in Fasting Triglycerides Between Baseline and Month 12
Time frame: Baseline, Month 12
Changes in Diastolic Blood Pressure Between Baseline and Month 12
Time frame: Baseline, Month 12
Changes in Systolic Blood Pressure Between Baseline and Month 12
Time frame: Baseline, Month 12
Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12
Time frame: Baseline to Month 12
Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline
Time frame: baseline
Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline
Time frame: baseline
Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline
Time frame: baseline
Factor of Older Age Associated With Treatment Choice at Baseline
Time frame: baseline
Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Time frame: baseline
Factor of Greater Height Associated With Treatment Choice at Baseline
Time frame: baseline
Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline
Time frame: baseline
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.
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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
50 sites 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 Mellitus, run by AstraZeneca at 50 sites in Italy.
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 6 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 50 sites in Italy. 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 16 Jan 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?
Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12. (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.