Dipeptidyl Peptidase-4 Inhibitors and Risk of Inflammatory Bowel Disease among Patients with Type 2 Diabetes Mellitus

Study identification

• EU PAS number:
  EUPAS26245
• Study ID:
  26246
• Official title and acronym:
  Dipeptidyl Peptidase-4 Inhibitors and Risk of Inflammatory Bowel Disease among Patients with Type 2 Diabetes Mellitus
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  To evaluate the association between new use of dipeptidyl peptidase-4 inhibitor (DPP4i) and inflammatory bowel disease (IBD) risk, we will implement an active comparator, new user (ACNU) cohort design using MarketScan® Commercial Claims and Encounters Database (2007-2015) and 20% random sample of Medicare fee-for-service data (2007-2015). We will compare DPP4i with therapeutic alternatives, sulfonylureas (SU) and thiazolidinediones (TZD), respectively. The primary outcome is incident IBD, defined by IBD diagnosis (ICD-9-CM codes 555.x and 556.x) preceded by colonoscopy and biopsy within 30 days before diagnosis, and followed by IBD treatment within 30 days after diagnosis. We will start follow-up for the outcome 180 days after the second prescription (latency period) and exclude patients with the outcome within 180 days after their second prescription. Similarly, follow-up for IBD events will continue 180 days (the “carry-over” period) after treatment changes or discontinuation. Covariates include demographics, comorbidities (diabetes, pre-existing autoimmune, gastroenterological, and cardiovascular diseases), medications, and health care utilizations.We will perform propensity score and standardized mortality/morbidity ratio (SMR) weighting to control for measured baseline confounding, estimate adjusted hazard ratios (aHRs 95% CI) using weighted Cox proportional hazards models and pool aHRs across cohorts with the use of random-effects meta-analysis models. We will perform multiple sensitivity analyses to examine the robustness of our primary results, including changing latency and carry-over periods, initial treatment analysis, using modified outcome definitions, using a modified exclusion criteria, censoring patients received medications that could potentially induce or progress IBD during follow-up.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of North Carolina at Chapel Hill

Department of Epidemiology

Study timelines

Date when funding contract was signed

Planned: 31/12/2018

Study start date

Planned: 01/08/2018

Actual: 22/08/2018

Date of final study report

Planned: 30/06/2019

Sources of funding

Other

More details on funding

Unfunded

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable