ACTIVE_NOT_RECRUITING

Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

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Conditions

Diabetes Mellitus, Type 2Glucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesIncretins

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.

Official Title

A Phase 3, Randomized, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Semaglutide Once Weekly in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

Quick Facts

Study Start:2024-02-21
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06260722

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have Type 2 Diabetes (T2D)
  2. * Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol)
  3. * Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening
  4. * Are of stable weight for at least 90 days prior to screening
  5. * Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m\^2)
  1. * Have Type 1 Diabetes (T1D)
  2. * Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening
  3. * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
  4. * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
  5. * Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory
  6. * Have a prior or planned surgical treatment for obesity
  7. * Have New York Heart Association Functional Classification IV congestive heart failure
  8. * Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening
  9. * Have a known clinically significant gastric emptying abnormality
  10. * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
  11. * Have any lifetime history of a suicide attempt
  12. * Had chronic or acute pancreatitis
  13. * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2
  14. * Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.

Contacts and Locations

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

University of Alabama - Department of Nutrition Sciences
Birmingham, Alabama, 35294
United States
Neighborhood Healthcare Institute of Health
Escondido, California, 92025
United States
Long Beach Research Institute
Long Beach, California, 90805
United States
Valley Clinical Trials, Inc.
Northridge, California, 91325
United States
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, 91730
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Arrow Clinical Trials
Daytona Beach, Florida, 32117
United States
New Age Medical Research Corporation
Miami, Florida, 33186
United States
South Broward Research
Miramar, Florida, 33027
United States
Clinical Research of Central Florida
Winter Haven, Florida, 33880
United States
Herman Clinical Research
Suwanee, Georgia, 30024
United States
North Georgia Clinical Research
Woodstock, Georgia, 30189
United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96817
United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
United States
Deaconess Clinic - Gateway Health Center
Newburgh, Indiana, 47630
United States
IMA Clinical Research Monroe - Armand
Monroe, Louisiana, 71201
United States
MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland, 20782
United States
Brigham and Women's Hospital Diabetes Program
Boston, Massachusetts, 02115
United States
NECCR PrimaCare Research
Fall River, Massachusetts, 02721
United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
United States
Palm Research Center Tenaya
Las Vegas, Nevada, 89128
United States
Palm Research Center Sunset
Las Vegas, Nevada, 89148
United States
NYC Research INC
Long Island City, New York, 11106
United States
Medication Management
Greensboro, North Carolina, 27405
United States
Remington Davis Clinical Research
Columbus, Ohio, 43215
United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
United States
Central States Research
Tulsa, Oklahoma, 74136
United States
The Corvallis Clinic, P.C.
Corvallis, Oregon, 97330
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
United States
Valley Institute of Research - Fort Worth
Fort Worth, Texas, 76164
United States
Juno Research
Houston, Texas, 77040
United States
Southern Endocrinology Associates
Mesquite, Texas, 75149
United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
United States
Texas Valley Clinical Research
Weslaco, Texas, 78596
United States
Medrasa Clinical Research
Wylie, Texas, 75098
United States
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801
United States
IMA Clinical Research West Virginia
Morgantown, West Virginia, 26505
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-21
Study Completion Date2027-03

Study Record Updates

Study Start Date2024-02-21
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Glucose Metabolism Disorders
  • Metabolic Diseases
  • Endocrine System Diseases
  • Incretins

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2