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Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT01060059 (opens ClinicalTrials.gov in a new tab)Other idH8O-IT-B014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
888 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Not stated
Countries
1 country

Italy

Start
Apr 2010
Primary completion
May 2012
Completion
May 2012
First posted
2 Feb 2010 (estimated)
Last update posted
9 Apr 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. Ph –

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

    NCT01060059

    Apr 2010 to May 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • exenatideDrug
  • basal insulinDrug

Arms2

  • Other

    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.

  • Other

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.

Secondary outcomes(20)

  1. Changes in HbA1c From Baseline to Month 12

    Time frame · Baseline, Month 12

    Registry description

    Changes in HbA1c from Baseline to Month 12

  2. Changes in Fasting Blood Glucose From Baseline to Month 12

    Time frame · Baseline, Month 12

    Registry description

    Changes in Fasting Blood Glucose From Baseline to Month 12

  3. Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12

    Time frame · Baseline, Month 12

    Registry description

    Percentage of Patients with HbA1c Reduction from Baseline \>= 1.0% at Month 12

  4. Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12

    Time frame · Month 12

    Registry description

    Percentage of Patients Achieving HbA1c Concentration \<=7.0% at Month 12

  5. Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12

    Time frame · Month 12

    Registry description

    Percentage of Patients Achieving HbA1c Concentration \<6.5% at Month 12

  6. Changes in Weight From Baseline to Month 12

    Time frame · Baseline, Month 12

    Registry description

    Changes in Weight From Baseline to Month 12

  7. Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12

    Time frame · Baseline, Month 12

    Registry description

    Percentage of Patients Achieving a Weight Decrease \>=3% between Baseline and Month 12

  8. Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12

    Time frame · Baseline, Month 12

    Registry description

    Percentage of Patients Achieving a Weight Decrease \>=5% between Baseline and Month 12

  9. Changes in Fasting Total Cholesterol Between Baseline and Month 12

    Time frame · Baseline, Month 12

    Registry description

    Changes in Fasting Total Cholesterol Between Baseline and Month 12

  10. Changes in Fasting HDL Between Baseline and Month 12

    Time frame · Baseline, Month 12

    Registry description

    Changes in Fasting HDL Between Baseline and Month 12

  11. Changes in Fasting LDL Between Baseline and Month 12

    Time frame · Baseline, Month 12

    Registry description

    Changes in Fasting LDL Between Baseline and Month 12

  12. Changes in Fasting Triglycerides Between Baseline and Month 12

    Time frame · Baseline, Month 12

    Registry description

    Changes in Fasting Triglycerides Between Baseline and Month 12

  13. Changes in Diastolic Blood Pressure Between Baseline and Month 12

    Time frame · Baseline, Month 12

    Registry description

    Changes in Diastolic Blood Pressure Between Baseline and Month 12

  14. Changes in Systolic Blood Pressure Between Baseline and Month 12

    Time frame · Baseline, Month 12

    Registry description

    Changes in Systolic Blood Pressure Between Baseline and Month 12

  15. Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12

    Time frame · Baseline to Month 12

    Registry description

    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.

  16. Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline

    Time frame · baseline

    Registry description

    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.

  17. Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline

    Time frame · baseline

    Registry description

    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 (%).

  18. Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline

    Time frame · baseline

    Registry description

    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.

  19. Factor of Older Age Associated With Treatment Choice at Baseline

    Time frame · baseline

    Registry description

    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.

  20. Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline

    Time frame · baseline

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline, Month 12

Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.

GroupValue (percentage of patients)
Exenatide35.0
Basal Insulin15.8
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline, Month 12

Changes in HbA1c From Baseline to Month 12

GroupValue (percent)Spread
Exenatide-1.11.40
Basal Insulin-1.41.49
Secondary outcomeMean· Baseline, Month 12

Changes in Fasting Blood Glucose From Baseline to Month 12

GroupValue (mg/dL)Spread
Exenatide-26.757.05
Basal Insulin-51.464.53
Secondary outcomeNumber· Baseline, Month 12

Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12

GroupValue (percentage of patients)
Exenatide49.4
Basal Insulin51.1
Secondary outcomeNumber· Month 12

Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12

GroupValue (percentage of patients)
Exenatide39.0
Basal Insulin22.2
Secondary outcomeNumber· Month 12

Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12

GroupValue (percentage of patients)
Exenatide13.1
Basal Insulin4.9
Secondary outcomeMean· Baseline, Month 12

Changes in Weight From Baseline to Month 12

GroupValue (kg)Spread
Exenatide-3.95.92
Basal Insulin0.24.78
Secondary outcomeNumber· Baseline, Month 12

Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12

GroupValue (percentage of patients)
Exenatide43.0
Basal Insulin17.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
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. exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day–11 / 44419 / 444
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. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment–10 / 4389 / 438

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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