Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05073692 |
| Other study ID # |
739857 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
August 30, 2025 |
Study information
| Verified date |
November 2023 |
| Source |
Kaiser Permanente |
| Contact |
Romain S. Neugebauer, PhD |
| Phone |
510-891-3234 |
| Email |
Romain.S.Neugebauer[@]kp.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study is designed to help patients with type 2 diabetes and their clinicians: (a)
identify which glucose lowering medications have the most favorable effects on heart health
and other patient-important outcomes, (b) inform the timing of medication initiation, and (c)
identify whether medication benefits apply equally to all adults with type 2 diabetes, or may
be different based on age, sex, race/ethnicity, baseline heart health status, baseline renal
function, or other factors.
Description:
The study will conduct head-to-head comparisons of type 2 diabetes mellitus (T2DM) treatment
strategies using observational data from real-world clinical settings to assess
cardiovascular disease (CVD) outcomes and other patient-centered outcomes in T2DM patients
with moderate baseline CVD risk who are treated with each of these four classes of
glucose-lowering medications known as SGLT2, GLP-1RA, DPP4, and SU. To mitigate bias concerns
related to confounding and informative loss to follow-up, analyses will be based on modern
causal inference methods combined with machine learning that emulate intention-to-treat (ITT)
and per-protocol (PP) analyses of pragmatic randomized trials with active comparators to
provide the most robust and precise estimates of relative and absolute effects we would
expect in usual care settings.
Specific Aims and Hypotheses:
Aim 1. Compare the effect off SGLT21, GLP-1RA, DPP4, and SU on each study outcome in adults
with T2DM when each type of medication is (a) initiated as second-line therapy after
metformin, and (b) initiated as first-, second-, or third-line therapy, or after any history
of glucose-lowering therapy independent of prior metformin use.
Aim 2. Compare the effect on each study outcome of earlier versus later initiation of SGLT2i,
GLP-1RA, DPP4, SU as first-, or second-, or third-line therapy, or after any history of
glucose-lowering therapy triggered by various changes in A1C, or CVD risk, or other patient
characteristics.
Aim 3. Assess in each of the prior analyses whether the treatment effects on study outcomes
vary across categories of baseline CVD risk and CVD event history, renal function, congestive
heart failure status, age, sex and race/ethnicity, or other patient characteristics.
Aim 4. Evaluate trends in new pharmacy dispensing of SGLT2i and GLP1-RA between 2014 and
2021, in aggregate and by age, sex, race and ethnicity and concurrent T2DM drug use
Aim 5. Evaluate trends in new pharmacy dispensing of SGLT2i and GLP1-RA between 2014 and
2021, by baseline ASCVD, heart failure and diabetic kidney disease.
Aim 6. Describe primary adherence, secondary adherence, and persistence for diabetes
medication
Aim 7. Compare rates of primary non-adherence, secondary adherence, and medication
persistence for brand name and generic medications for type 2 diabetes in specific subgroups
of patients
Aim 8. Examine trends in medication possession for brand name medications over the course of
the calendar year
Glucose-lowering medications will be compared at both the class and agent level. The key
outcomes that will be considered are MACE 3-point, Myocardial Infarction, Stroke, Heart
Failure, Hospitalization, Coronary or Carotid Artery Stent or Bypass Procedure, CVD
Mortality, Overall Mortality. Additional patient-centered outcomes will be specified based on
insights from stakeholder members of the research team.
