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Comparison of the Effectiveness and Tolerability of Exenatide Once-weekly Compared to Basal Insulins

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ClinicalTrials.gov Identifier: NCT02974244
Recruitment Status : Completed
First Posted : November 28, 2016
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:

Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as necessary for other glucagon-like peptide-1 agonists, and appears to have other advantages, such as reducing insulin resistance, reducing weight, and improving blood pressure and lipid profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes in customary clinical care is unknown.

The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative to basal insulin initiated as first-ever injectable therapeutic regimens used in customary clinical care. Patients who initiated treatment with Bydureon or basal insulin between July 2011 and March 2015 will be recruited into the study cohorts from Optum's database of electronic health records. The two treatment cohorts will be matched by propensity score method.Clinical outcomes of HbA1c, weight, and gastrointestinal symptoms and hypoglycemia are investigated.


Condition or disease Intervention/treatment
Type 2 Diabetes Drug: exenatide once weekly Drug: basal insulin

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Cohort Study of the Benefits of Bydureon in Customary Clinical Care in the United States
Actual Study Start Date : October 28, 2014
Actual Primary Completion Date : October 28, 2014
Actual Study Completion Date : October 28, 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
exenatide once weekly
type 2 diabetes who initiated exenatide once weekly treatment in the index period
Drug: exenatide once weekly
exenatide treatment in the customary clinical care in the USA

basal insulin
type 2 diabetes patients who initiated basal insulin treatment in the index period
Drug: basal insulin
basal insulin treatment in the customary clinical care in USA




Primary Outcome Measures :
  1. Changes from baseline in HbA1c (%) [ Time Frame: one year post-index ]
    To evaluate changes in HbA1c from baseline one year after starting treatment with exenatide once weekly and basal insulin

  2. Changes from baseline in weight (kg) [ Time Frame: one year post-index ]
    To evaluate changes in weight (kg) from baseline one year after starting treatment with exenatide once weekly and basal insulin


Secondary Outcome Measures :
  1. Frequency of hypoglycemia [ Time Frame: one year post-index ]
    to evaluate frequency of hypoglycemia in association with initiation of therapy with exenatide once weekly and basal insulin

  2. Frequency of nausea [ Time Frame: One year post-index ]
    to evaluate frequency of nausea in association with initiation of therapy with exenatide once weekly and basal insulin

  3. Frequency of vomiting [ Time Frame: one year post-index ]
    to evaluate frequency of vomiting in association with initiation of therapy with exenatide once weekly and basal insulin

  4. Frequency of diarrhea and constipation [ Time Frame: One year post-index ]
    to evaluate frequency of diarrhea and constipation in association with initiation of therapy with exenatide once weekly and basal insulin



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This cohort study compares injectable-naive exenatide once-weekly and basal insulin initiators. The study cohorts were drawn from an Optum's Electronic Health Records database that integrates records from many medical groups and hospitals in the United States representing over 25,000 physicians and over 25 million patients in ordinary clinical practice. The Electronic Health Records captures clinical, operational, and financial information that physicians record at the time of care. This information includes diagnoses, procedures, medications (prescribed and administered), clinical measures (biometric and laboratory values), and clinical notes (e.g., physician, pathology, and radiology notes).
Criteria

Inclusion Criteria:

  • At least 18 years old;
  • had received care documented in Electronic Health Records (including at least one out-patient provider visit) for a minimum of 6-months prior index date;
  • had at least one diagnosis of type 2 diabetes by The International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM: 250.X0 or 250.X2) prior to and including the date of the study drug initiation, with no prior diagnosis of type1 diabetes (ICD-9-CM: 250.X1 or 250.X3), or gestational diabetes within the 6-months prior to index date;
  • No evidence of prior injectable antidiabetic treatment, specifically no dispensing of a GLP-1RA or any insulin during the 6-months baseline period prior to study drug initiation

Exclusion Criteria:

  • Prior diagnosis of type1 diabetes (ICD-9-CM: 250.X1 or 250.X3), or gestational diabetes within the 6-months prior to index date;
  • Prior dispensing of a GLP-1RA or any insulin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974244


Locations
United States, Massachusetts
Optum Epidemiology
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Anita M Loughlin, Ph.D Optum, Inc.

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02974244     History of Changes
Other Study ID Numbers: D5551R00008
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by AstraZeneca:
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Exenatide
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists