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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01060059
First received: January 26, 2010
Last updated: March 7, 2012
Last verified: March 2012
History of Changes
  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:

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:

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

  Hide Study Locations
Locations
Italy
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Acquaviva delle Fonti, Italy
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Anzio, Italy
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Aosta, Italy
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Avezzano, Italy
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Bagno a Ripoli, Italy
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Bassano del Grappa, Italy
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Benevento, Italy
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Bergamo, Italy
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Bologna, Italy
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Borgo San Lorenzo, Italy
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Brindisi, Italy
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Cagliari, Italy
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Caltanissetta, Italy
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Campi Salentina, Italy
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Canicattì, Italy
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Casarano, Italy
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Caserta, Italy
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Castelfranco Veneto, Italy
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Catanzaro, Italy
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Cesena, Italy
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Chieri, Italy
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Chieti, Italy
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Cisternino, Italy
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Copertino, Italy
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Cremona, Italy
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Fermo, Italy
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Ferrara, Italy
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Fidenza, Italy
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Firenze, Italy
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Forlì, Italy
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Frascati, Italy
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Genova, Italy
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Germaneto, Italy
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Gissi, Italy
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Lecce, Italy
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Leno, Italy
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Licata, Italy
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Livorno, Italy
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Lucca, Italy
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Manfredonia (Le), Italy
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Mariano Comense, Italy
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Matera, Italy
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Messina, Italy
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Mestre, Italy
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Milano, Italy
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Montebelluna, Italy
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Monza, Italy
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Napoli, Italy
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Novara, Italy
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Olbia, Italy
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Oristano, Italy
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Orvieto, Italy
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Palermo, Italy
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Palmi, Italy
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Paola, Italy
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Parma, Italy
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Partinico, Italy
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Pavia, Italy
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Pisa, Italy
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Potenza, Italy
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Ragusa, Italy
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Ravenna, Italy
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Rimini, Italy
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Roma, Italy
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San Giovanni Rotondo, Italy
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Sassari, Italy
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Schio, Italy
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Sesto San Giovanni, Italy
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Sienna, Italy
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Terni, Italy
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Treviso, Italy
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Trieste, Italy
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Varese, Italy
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Venezia, Italy
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Vicenza, Italy
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 19, 2013