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

NCT02974244 | Completed

• 1 other identifier: D5551R00008
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes

Outcome Measures

Primary Outcomes (2)

• Changes from baseline in HbA1c (%)

  To evaluate changes in HbA1c from baseline one year after starting treatment with exenatide once weekly and basal insulin

  one year post-index

• Changes from baseline in weight (kg)

  To evaluate changes in weight (kg) from baseline one year after starting treatment with exenatide once weekly and basal insulin

  one year post-index

Secondary Outcomes (4)

• Frequency of hypoglycemia

  one year post-index

• Frequency of nausea

  One year post-index

• Frequency of vomiting

  one year post-index

• Frequency of diarrhea and constipation

  One year post-index

Study Arms (2)

exenatide once weekly

type 2 diabetes who initiated exenatide once weekly treatment in the index period

Drug: exenatide once weekly

basal insulin

type 2 diabetes patients who initiated basal insulin treatment in the index period

Drug: basal insulin

Interventions

exenatide once weekly DRUG

exenatide treatment in the customary clinical care in the USA

exenatide once weekly

basal insulin DRUG

basal insulin treatment in the customary clinical care in USA

basal insulin

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Optum Epidemiology

Boston, Massachusetts, 02215, United States

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Anita M Loughlin, Ph.D

  Optum, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 28, 2016
• Study Start: October 28, 2014
• Primary Completion: October 28, 2014
• Study Completion: October 28, 2014
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

US (1)