Characteristics of Patients With Type 2 Diabetes Mellitus Receiving Treatment With Dapagliflozin Versus Sitagliptin: An Analysis of Commercial Claims and Linked Laboratory Data

NCT03078049 | Completed

• 1 other identifier: D1690R00034
• Study Type: observational
• Target: 11,971
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: In order to compare the real-world use of commonly prescribed second-line oral diabetes therapies, real-world data comparing patients receiving treatment with dapagliflozin vs sitagliptin are needed, and limited resource use and cost data exist for patients initiating dapagliflozin in the real-world setting. Objectives: Primary: The primary objective of this study is to compare real-world health care resource utilization and costs following treatment with dapagliflozin versus sitagliptin. Secondary: The secondary objectives of this study are to assess clinical outcomes and treatment patterns among patients receiving treatment with dapagliflozin versus sitagliptin. Study Design: Retrospective cohort study. Target Subject Population: Patients receiving treatment with either dapagliflozin or sitagliptin will be evaluated. Study Variable(s): Primary Variables: Health care resource utilization and costs Secondary Variables: Demographics measured at the index date, Quan-Charlson Comorbidity score, measured during the baseline period, Agency for Healthcare Research and Quality (AHRQ)-based comorbidity measures, receipt of other antidiabetic medication classes during the baseline and follow-up periods, number and percentage of patients with a diagnosis of obesity during the baseline or follow-up periods, treatment patterns during the follow-up period (i.e., index dose, duration of treatment, discontinuation, adherence, receipt of additional antidiabetic medication classes), HbA1c outcomes (among subgroup of patients with linked laboratory data, sample size permitting), renal impairment, hypoglycemia as defined by a claims-based algorithm. Statistical Methods: Initial analyses will be descriptive in nature and entail the tabular display of mean values, medians, ranges, and standard deviations of continuous variables of interest (e.g., patient age) and frequency distributions for categorical variables (e.g., sex, geographic location). Outcomes will be compared between patients receiving dapagliflozin versus sitagliptin using univariate tests. Propensity score matching will be undertaken to reduce bias in the comparison of patients receiving treatment with dapagliflozin versus sitagliptin. Following matching, demographics and baseline characteristics will be assessed using standardized differences to determine balance in the post-matched sample. Outcomes will be assessed using tests for paired data (paired t-tests, signed rank tests, McNemar's tests).

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (7)

• Inpatient Stays

  Number of patients with at least one hospital stay, number of unique stays and average length of stay.

  6 months

• Emergency Department Visits

  Number of patients with at least one emergency department visit and number of emergency department visits.

  6 months

• Ambulatory visits (physician office visits and outpatient visits)

  Number of patients with at least one visit and number of visits.

  6 months

• Other medical costs

  Per-patient costs for medical services outside of inpatient hospitalization, emergency department visits, and ambulatory visits.

  6 months

• Total medical costs

  Per-patient costs for all medical claims

  6 months

• Pharmacy Costs

  Count of unique medications filled, count of medication fills, and per-patient costs for all pharmacy claims.

  6 months

• Total costs

  Per-patient costs for all medical and pharmacy claims.

  6 months

Secondary Outcomes (7)

• Adherence

  6 months

• Discontinuation of index therapy

  6 months

• Persistence with index therapy

  6 months

• Follow-up within-class index medication switching

  6 months

• Follow-up index medication switching

  6 months

Study Arms (2)

Dapagliflozin

Patients taking dapagliflozin

Sitagliptin

Patients take sitagliptin

Eligibility Criteria

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

Study Population

Both Male and Female 18+

You may qualify if:

• A prescription claim for either dapagliflozin or sitagliptin between on after January 1, 2014 (note: patients receiving dapagliflozin/metformin combination therapy (Xigduo), sitagliptin/metformin (Janumet/Janumet XR), or sitagliptin/simvastatin (Juvisync) will be included in the study population). The date of the first observed claim for either dapagliflozin or sitagliptin will define the index date.
• Continuous medical and pharmacy benefits for a 6-month baseline period.
• At least 1 diagnosis of T2DM in any position (ICD-9-CM and ICD-10-CM diagnosis codes are provided in accompanying Excel file) during the 6-month baseline period or during the 12- month follow-up period

You may not qualify if:

• Receipt of either a SGLT-2 inhibitor or DPP-4 inhibitor during the 6-month baseline period.
• A diagnosis of type 1 diabetes mellitus (T1DM) in any position during the baseline period.
• A diagnosis of gestational diabetes mellitus (GDM) or pregnancy in any position during the 6-month baseline period or 12-month follow-up period.

Sponsors & Collaborators

• AstraZeneca: lead
• Optum, Inc.: collaborator

Study Sites (1)

Research Site

Wilmington, Delaware, 19803, United States

Location

Related Links

• ClinicalStudyReportSynopsis \_D1690R00034

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

• Eric Wittbrodt, PharmD, MPH

  AstraZeneca

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 13, 2017
• Study Start: March 31, 2017
• Primary Completion: April 30, 2017
• Study Completion: May 31, 2017
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)