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

Purpose

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.

Condition	Intervention
Type 2 Diabetes Mellitus	Drug: exenatide Drug: basal insulin

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin human Exenatide

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, LLC.:

Primary Outcome Measures:

To estimate in a type 2 Diabetes Mellitus population initiating exenatide or basal insulin therapy after oral treatment failure, the proportion of patients in each cohort who achieve glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the following in each cohort of patients: >HbA1c change from baseline >Change of fasting blood glucose from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To evaluate the following in each cohort of patients: >Proportion of patients with HbA1c reduction from baseline ≥ 1% and proportion of patients reaching HbA1c target values of ≤7% and <6.5% >Body weight change and BMI change from baseline [ Time Frame: 12 month ] [ Designated as safety issue: No ]
To evaluate the following in each cohort of patients: >Proportion of patients achieving a weight decrease of ≥ 3% and ≥ 5%, respectively >Baseline characteristics of patients and factors associated with treatment choice [ Time Frame: 12 month ] [ Designated as safety issue: No ]
To evaluate the following in each cohort of patients: >Changes of cardiovascular risk markers (if available): fasting blood lipids, blood pressure, waist circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To evaluate the following in each cohort of patients: >Incidence and severity of side-effects including hypoglycaemia and gastrointestinal symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To evaluate the following in each cohort of patients: >Change in patient reported outcomes (including health status, treatment satisfaction, psychological well-being) in each cohort [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To evaluate the following in each cohort of patients: >Final exenatide or insulin total daily dose and average dose of exenatide or insulin [mcg/day or IU/day] for the time of exposure >Duration of treatment with exenatide or basal insulin [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To evaluate the following in each cohort of patients: >Adherence to the treatment prescribed >Reasons for significant changes of antihyperglycemic treatment >Resource use associated with treatment for diabetes of patients in each cohort [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	896
Study Start Date:	May 2010
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.	Drug: exenatide subcutaneous injection, 5mcg or 10mcg, twice a day Other Name: BYETTA
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.	Drug: basal insulin subcutaneous injection, dosing according to physician's clinical judgment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The targeted population consists of adult patients with type 2 diabetes mellitus treated in outpatient setting by specialists.

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060059

Show 75 Study Locations

Sponsors and Collaborators

Amylin Pharmaceuticals, LLC.

Eli Lilly and Company

Investigators

Study Director:

Chief Medical Officer, MD

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:	NCT01060059 History of Changes
Other Study ID Numbers:	H8O-IT-B014
Study First Received:	January 26, 2010
Last Updated:	March 7, 2012
Health Authority:	Italy: Ethics Committee

Keywords provided by Amylin Pharmaceuticals, LLC.:

diabetes; exenatide; Byetta; basal insulin; Amylin; Lilly

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Exenatide
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013