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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01060059
First received: January 26, 2010
Last updated: February 21, 2014
Last verified: February 2014
  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:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.


Secondary Outcome Measures:
  • Changes in HbA1c From Baseline to Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Changes in HbA1c from Baseline to Month 12

  • Changes in Fasting Blood Glucose From Baseline to Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Changes in Fasting Blood Glucose From Baseline to Month 12

  • Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Percentage of Patients with HbA1c Reduction from Baseline >= 1.0% at Month 12

  • Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12

  • Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12

  • Changes in Weight From Baseline to Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Changes in Weight From Baseline to Month 12

  • Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Percentage of Patients Achieving a Weight Decrease >=3% between Baseline and Month 12

  • Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Percentage of Patients Achieving a Weight Decrease >=5% between Baseline and Month 12

  • Changes in Fasting Total Cholesterol Between Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Changes in Fasting Total Cholesterol Between Baseline and Month 12

  • Changes in Fasting HDL Between Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Changes in Fasting HDL Between Baseline and Month 12

  • Changes in Fasting LDL Between Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Changes in Fasting LDL Between Baseline and Month 12

  • Changes in Fasting Triglycerides Between Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Changes in Fasting Triglycerides Between Baseline and Month 12

  • Changes in Diastolic Blood Pressure Between Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Changes in Diastolic Blood Pressure Between Baseline and Month 12

  • Changes in Systolic Blood Pressure Between Baseline and Month 12 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    Changes in Systolic Blood Pressure Between Baseline and Month 12

  • Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12 [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: Yes ]

    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.


  • Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 (%).

  • Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Factor of Older Age Associated With Treatment Choice at Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Factor of Greater Height Associated With Treatment Choice at Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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) .

  • 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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 888
Study Start Date: April 2010
Study Completion Date: May 2012
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:   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

  Show 50 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Eli Lilly and Company
Investigators
Study Director: James Malone, MD Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01060059     History of Changes
Other Study ID Numbers: H8O-IT-B014
Study First Received: January 26, 2010
Results First Received: July 31, 2013
Last Updated: February 21, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Bristol-Myers Squibb:
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 April 21, 2014