BRIDGE-T2D: A REAL-WORLD FRAMEWORK AND PROSPECTIVE STUDY DESIGN FOR EVALUATING IMPACT OF DUAL GLYCEMIC AND WEIGHT CONTROL IN TYPE 2 DIABETES
Author(s)
Jay Bae, PhD1, Rachel Parry, PharmD, PhD2, Kendra Terrell, MPH1, Di Zhang, PhD1, Fatih Tangi, MD, PhD1, Alana Washington, MBA, PharmD1, Karishma Desai, PhD2, Judith J. Stephenson, MS2, Michael Grabner, PhD2, Eric Stanek, PharmD2, Chia-Chen Teng, MS2, Edward E. Gregg, PhD3, David Maahs, MD, PhD4, Steven Kahn, MB, ChB5.
1Eli Lilly and Company, Indianapolis, IN, USA, 2Carelon Research, Wilmington, DE, USA, 3Royal College of surgeons in Ireland, Dublin, Dublin, Ireland, 4Stanford University School of Medicine, Stanford, CA, USA, 5University of Washington School of Medicine, Seattle, WA, USA.
1Eli Lilly and Company, Indianapolis, IN, USA, 2Carelon Research, Wilmington, DE, USA, 3Royal College of surgeons in Ireland, Dublin, Dublin, Ireland, 4Stanford University School of Medicine, Stanford, CA, USA, 5University of Washington School of Medicine, Seattle, WA, USA.
OBJECTIVES: While glycemic control influences long-term type 2 diabetes (T2D) outcomes, the incremental contribution of tandem body weight reduction remains less well defined. Although guidelines emphasize weight management, intentional dual glycemic and weight control remains under-implemented in clinical practice, driven in part by evidence gaps. The BRIDGE-T2D study has been designed as a real-world observational framework to evaluate the impact on achieving dual-control on outcomes in individuals with T2D and overweight/obesity.
METHODS: BRIDGE-T2D is a hybrid retrospective/prospective, non-interventional cohort study using Carelon Research’s Healthcare Integrated Research Database, linking administrative claims, electronic health records, and social drivers of health. Adults with overweight/obesity and T2D enter the cohort at new treatment initiation, switching, or augmentation. Patients who achieve dual-control vs. single/no control are determined at a prespecified 6-month landmark using prespecified HbA1c and weight combinations of overall changes and threshold achievement, with maximum 6-year follow-up. The design enables evaluation of major adverse cardiovascular events (MACE), all-cause mortality, cardiometabolic effects, and healthcare resource utilization. Landmark analyses are the primary approach, with time-varying exposure analyses for sensitivity. Confounding will be addressed via propensity scores and quantitative bias analysis. We project >80% power (alpha=0.05) to detect a 20% difference in MACE (primary end point) risk in our main comparator groups, assuming a 4%/year rate among comparators.
RESULTS: This framework defines dual-control as an ideal treatment modality construct in T2D-diagnosed individuals, enabling real-world evaluation of outcomes independent of treatments. The study design protocol will be prospectively registered, with preliminary findings expected from 2027 onward.
CONCLUSIONS: BRIDGE-T2D provides an adequately powered, clinically relevant framework to generate real-world evidence on dual glycemic and weight control and its clinical and economic value in T2D at a time when dual-control is increasingly recognized as a central treatment goal, but supporting real-world disease-state evidence remains limited.
METHODS: BRIDGE-T2D is a hybrid retrospective/prospective, non-interventional cohort study using Carelon Research’s Healthcare Integrated Research Database, linking administrative claims, electronic health records, and social drivers of health. Adults with overweight/obesity and T2D enter the cohort at new treatment initiation, switching, or augmentation. Patients who achieve dual-control vs. single/no control are determined at a prespecified 6-month landmark using prespecified HbA1c and weight combinations of overall changes and threshold achievement, with maximum 6-year follow-up. The design enables evaluation of major adverse cardiovascular events (MACE), all-cause mortality, cardiometabolic effects, and healthcare resource utilization. Landmark analyses are the primary approach, with time-varying exposure analyses for sensitivity. Confounding will be addressed via propensity scores and quantitative bias analysis. We project >80% power (alpha=0.05) to detect a 20% difference in MACE (primary end point) risk in our main comparator groups, assuming a 4%/year rate among comparators.
RESULTS: This framework defines dual-control as an ideal treatment modality construct in T2D-diagnosed individuals, enabling real-world evaluation of outcomes independent of treatments. The study design protocol will be prospectively registered, with preliminary findings expected from 2027 onward.
CONCLUSIONS: BRIDGE-T2D provides an adequately powered, clinically relevant framework to generate real-world evidence on dual glycemic and weight control and its clinical and economic value in T2D at a time when dual-control is increasingly recognized as a central treatment goal, but supporting real-world disease-state evidence remains limited.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO8
Topic
Clinical Outcomes, Epidemiology & Public Health, Real World Data & Information Systems
Topic Subcategory
Clinical Outcomes Assessment, Relating Intermediate to Long-term Outcomes
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Diabetes/Endocrine/Metabolic Disorders (including obesity)