Exenatide and Basal Insulins Use in the Real Setting: an Observational Study in Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060059
• Other study ID #: H8O-IT-B014
• Status: Completed
• Phase: N/A
• First received: January 26, 2010
• Last updated: March 20, 2015
• Start date: April 2010
• Est. completion date: May 2012

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 888
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Are inadequately controlled with single or multiple OHA as evidenced by an HbA1c > 7.0%

2. 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

3. Have not been treated with GLP-1 receptor agonist for more than 7 consecutive days within 3 months before entering the study

4. 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

5. Are not simultaneously participating in another study which includes an investigational drug or procedure at study entry

6. Have been fully informed and given their written consent for use of their data

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
• basal insulin
subcutaneous injection, dosing according to physician's clinical judgment

Locations

Country	Name	City	State
Italy	Research site	Acquaviva delle Fonti
Italy	Research site	Anzio
Italy	Research site	Bassano del Grappa
Italy	Research site	Bologna
Italy	Research site	Brindisi
Italy	Research site	Cagliari
Italy	Research site	Campi Salentina
Italy	Research site	Casarano
Italy	Research site	Caserta
Italy	Research site	Cesena
Italy	Research site	Chieri
Italy	Research site	Cisternino
Italy	Research site	Copertino
Italy	Research site	Cremona
Italy	Research site	Distretto Vittoria
Italy	Research site	Fermo
Italy	Research site	Ferrara
Italy	Research site	Fidenza
Italy	Research site	Firenze
Italy	Research site	Forlì
Italy	Research site	Genova
Italy	Research site	Germaneto
Italy	Research site	Lecce
Italy	Research site	Livorno
Italy	Research site	Lucca
Italy	Research site	Manfredonia (Le)
Italy	Research site	Mariano Comense
Italy	Research site	Messina
Italy	Research site	Milano
Italy	Research site	Monza
Italy	Research site	Napoli
Italy	Research site	Novara
Italy	Research site	Olbia
Italy	Research site	Palermo
Italy	Research site	Palmi
Italy	Research site	Parma
Italy	Research site	Pavia
Italy	Research site	Pisa
Italy	Research site	Potenza
Italy	Research site	Rimini
Italy	Research site	Roma
Italy	Research site	Rossano Scalo
Italy	Research site	Salerno
Italy	Research site	San Giovanni Rotondo
Italy	Research site	Schio
Italy	Research site	Sesto San Giovanni
Italy	Research site	Sienna
Italy	Research site	Treviso
Italy	Research site	Trieste
Italy	Research site	Varese

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Month 12	No
Secondary	Changes in HbA1c From Baseline to Month 12	Changes in HbA1c from Baseline to Month 12	Baseline, Month 12	No
Secondary	Changes in Fasting Blood Glucose From Baseline to Month 12	Changes in Fasting Blood Glucose From Baseline to Month 12	Baseline, Month 12	No
Secondary	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	Baseline, Month 12	No
Secondary	Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12	Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12	Month 12	No
Secondary	Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12	Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12	Month 12	No
Secondary	Changes in Weight From Baseline to Month 12	Changes in Weight From Baseline to Month 12	Baseline, Month 12	No
Secondary	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	Baseline, Month 12	No
Secondary	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	Baseline, Month 12	No
Secondary	Changes in Fasting Total Cholesterol Between Baseline and Month 12	Changes in Fasting Total Cholesterol Between Baseline and Month 12	Baseline, Month 12	No
Secondary	Changes in Fasting HDL Between Baseline and Month 12	Changes in Fasting HDL Between Baseline and Month 12	Baseline, Month 12	No
Secondary	Changes in Fasting LDL Between Baseline and Month 12	Changes in Fasting LDL Between Baseline and Month 12	Baseline, Month 12	No
Secondary	Changes in Fasting Triglycerides Between Baseline and Month 12	Changes in Fasting Triglycerides Between Baseline and Month 12	Baseline, Month 12	No
Secondary	Changes in Diastolic Blood Pressure Between Baseline and Month 12	Changes in Diastolic Blood Pressure Between Baseline and Month 12	Baseline, Month 12	No
Secondary	Changes in Systolic Blood Pressure Between Baseline and Month 12	Changes in Systolic Blood Pressure Between Baseline and Month 12	Baseline, Month 12	No
Secondary	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.	Baseline to Month 12	Yes
Secondary	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.	baseline	No
Secondary	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 (%).	baseline	No
Secondary	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.	baseline	No
Secondary	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.	baseline	No
Secondary	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.	baseline	No
Secondary	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) .	baseline	No
Secondary	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).	baseline	No