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N/A N=143 Randomized Diagnostic

SomaSignal Tests on Medical Management and Change in Risk in Patients With Diabetes

Diabetes Mellitus, Type 2

Enrolled (actual)
143
Serious AEs
0.7%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results — 45; 13; 8; 35 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SomaSignal Informed Medical Management SSCVD (Diagnostic_test); Standard of Care (Other)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Emory University
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results
45; 13; 8; 35
SECONDARY
Number of Participants With Changes in the SSCVD Results
6; 6; 23; 27; 18; 22
SECONDARY
Changes in Low-density Lipoprotein (LDL)
-30; -12; -45; 25
SECONDARY
Changes in High-density Lipoprotein (HDL)
5; 2; 8; 4
SECONDARY
Changes in Triglycerides (TG) Levels
-60; -15; -15; -45
SECONDARY
Changes in Glucose Levels
-45; 10; -10; 35
SECONDARY
Changes in Glycated Hemoglobin Test (HbA1C)
-1.8; 0.8; -2.2; -2.4
SECONDARY
Changes in Weight
-6.37; 0.87; -3.47; -3.18
SECONDARY
Changes in Body Mass Index (BMI)
-2.2; 0.3; -1.2; 1.1
SECONDARY
Number of Participants Who Experienced Changes in Tobacco Exposure
3; 1; 10; 5
SECONDARY
Number of Participants Who Experienced a Change in Physical Activity
25; 3; 12; 19
SECONDARY
Number of Participants Who Changed Their Dietary Habits
25; 3; 12; 19
SECONDARY
Physician Experience Questionnaire
SECONDARY
Change in Medication Possession Ratio

Summary

Despite the development of novel treatments, cardiovascular disease (CVD) remains the leading cause of death and disability. It has been observed in clinical practice, that the use of novel glycemia-lowering therapies with cardioprotective features remains profoundly low despite proven efficacy. It has been proposed that such low uptake is more related to insurance type and coverage than to risk assessment. While it can be easy to blame prescribing deficiencies on complacent physicians and/or over-frugal payors, SomaLogic believes there is more likely to be a fundamental problem with the cost and risk-effective allocation of such therapies, which are neither low in cost nor free of adverse events. As current clinical trials and guidelines tend to "bundle" participants together, there is an absence of individualized assessment of residual cardiovascular risk. This leads to physicians, participants, and payors being relatively uninformed as to the need for and/or likely benefits of such therapies in an individual. Simply giving every eligible participant a drug regardless of residual risk would be unaffordable and would create adverse effects and costs for people at low residual risk who might not actually benefit from the drugs. To resolve this lack of precision in risk assessment, SomaLogic has performed the largest ever proteomic program to date with over 36,000 samples from 26,000 participants in eleven clinical studies, for a total of over 180,000,000 protein measurements, to develop and validate a surrogate proteomic endpoint for cardiovascular outcomes. The SomaSignal Cardiovascular Risk (SSCVR) test, a 27-protein model encompassing ten biological systems.

Eligibility Criteria

Inclusion Criteria

  • Male and female participants 40 years and older
  • Diagnosis of type 2 diabetes (T2D) [according to American Diabetes Association (ADA) guidelines]
  • Able to provide consent
  • Eligible for (per drug label/guidelines) at least one of the following drug classes: sodium-glucose cotransporter 2 inhibitors (SGLT2i), proprotein convertase subtilisin/kexin type 9 (PCSK9i), glucagon-like peptide receptor agonists (GLP-1 RA) but not currently prescribed any of these classes of drugs, or only prescribed PCSK9i

Exclusion Criteria

  • Systemic Lupus Erythematous (SLE)
  • Pregnancy
  • Intolerance or contraindication for use of GLP-1 RA, SGLT2i, and PCSK9i
  • History of, an active, or untreated malignancy, in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years prior to, or are receiving or planning to receive therapy for cancer, at screening
  • Inability to understand English (currently, SomaSignal testing information, guides, educational materials, and reports are only available in English.)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05256706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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