Subanalyses of Elderly Type 2 Diabetes Patients or Type 2 Diabetes Patients With Renal Impairment

NCT02917057 | Completed

• 1 other identifier: D5551R00011
• Study Type: observational
• Target: 6,024
• 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 in patients with mild and moderate renal impairment and in elderly patients are 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 among elderly patients and patients with renal impairment. 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. Changes in HbA1c, weight, markers for renal function (estimated glomerular filtration rate (eGFR), serum creatinine, and albumin/creatinine ratio (ACR)), and incidences of gastrointestinal symptoms and hypoglycaemia are investigated for patients with different eGFR categories and with different ages.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Changes from baseline in HbA1c (%)

  To evaluate changes in HbA1c (%) from baseline after initiation of therapy with exenatide once-weekly in patients with different renal functions or age classes, as referred to basal insulin initiators of the same subgroups.

  one year post-index

• Changes from baseline in weight (kg)

  To evaluate changes in weight (kg) from baseline after initiation of therapy with exenatide once-weekly in patients with different renal functions or age classes, as referred to basal insulin initiators of the same subgroups.

  one year post-index

Secondary Outcomes (4)

• Changes from baseline in eGFR

  one year post-index

• Frequency of Hypoglycemia

  one year post-index

• Frequency of Nausea

  one year post-index

• Frequency of Vomiting

  one year post-index

Study Arms (2)

Exenatide once weekly initiators

Type 2 diabetes patients who initiated exenatide once weekly treatment during the index period

Drug: exenatide once weekly

Basal Insulin initiator cohort

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

Drug: basal insulin

Interventions

exenatide once weekly DRUG

Exenatide treatment in customary clinical care in the USA

Exenatide once weekly initiators

basal insulin DRUG

basal insulin tretament in the customary clinical care in USA

Basal Insulin initiator cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population was drawn from an Optum's Electronic Health Records (EHR) database. Injectable-naive type 2 diabetic patients who initiated therapy with either Exenatide once-weekly or basal insulin from January 2012 to January 2015, with follow-up through March 2015 were identified. The baseline period was defined as the 183 days (6-months) prior to date of study drug initiation (index date). Patients with Type 2 diabetes were identified using structured diagnosis fields and International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) codes. Initiations of Exenatide once-weekly or basal insulin were identified in the EHR data capturing prescribed medications using National Drug Codes (NDC).

You may qualify if:

• At least 18 years old;
• had received care documented in EHR (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 (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-1-RA or any insulin during the 6-months baseline period prior to study drug initiation

You may not qualify if:

• Prior diagnosis of type 1 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
• Missing data on renal function defined by eGFR or age

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Optum Epidemiology

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Loughlin AM, Qiao Q, Nunes AP, Ohman P, Ezzy S, Yochum L, Clifford CR, Gately R, Dore DD, Seeger JD. Effectiveness and tolerability of therapy with exenatide once weekly vs basal insulin among injectable-drug-naive elderly or renal impaired patients with type 2 diabetes in the United States. Diabetes Obes Metab. 2018 Apr;20(4):898-909. doi: 10.1111/dom.13175. Epub 2018 Jan 3.

  PMID: 29193561 BACKGROUND

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: September 8, 2016
• First Posted: September 28, 2016
• Study Start: August 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

US (1)