This study is being conducted to find out how well zenagamtide works and how safe it is compared to insulin glargine in participants with type 2 diabetes who are at higher risk of heart and blood vessel problems and are already taking 1 to 3 diabetes medications. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide, (the treatment being tested) or insulin glargine (a comparator) and which treatment participants get is decided by chance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,778
Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm (administration to the same body part throughout the study).
Insulin glargine U-100 will be administered subcutaneously using SoloSTAR pen-injector to one of the body parts: thigh, abdomen or upper arm (rotation of the injection site within body parts).
Univ of Alabama Birmingham
Birmingham, Alabama, United States
NOT_YET_RECRUITINGEastern Shore Rsrch Inst, LLC
Fairhope, Alabama, United States
RECRUITINGChambliss Clinical Trials, LLC
Montgomery, Alabama, United States
RECRUITINGHonor Health
Scottsdale, Arizona, United States
Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c)
Measured as percentage (%)-points
Time frame: From baseline (week 0) to week 52
Time to first occurrence of a 4-point major adverse cardiovascular events (MACE) endpoint consisting of: Cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for unstable angina
Measured as days
Time frame: From baseline (week 0) to 104 weeks or more
Relative change in body weight
Measured as percentage (%) change
Time frame: From baseline (week 0) to week 52
Superiority of zenagamtide versus insulin: Change in HbA1c
Measured as %-points
Time frame: From baseline (week 0) to week 52
Time to first occurrence of a 3-point MACE endpoint consisting of: CV death, non-fatal myocardial infarction and non-fatal stroke
Measured as Days
Time frame: From baseline (week 0) to 104 weeks or more
Change in waist circumference
Measured as centimeters
Time frame: From baseline (week 0) to week 52
Change in systolic blood pressure
Measured as millimeters of mercury (mmHg)
Time frame: From baseline (week 0) to week 52
Change in high-sensitivity C-reactive protein (hsCRP)
Measured as ratio to baseline
Time frame: From baseline (week 0) to week 52
Change in Triglycerides
Measured as ratio to baseline
Time frame: From baseline (week 0) to week 52
Change in Non-high-density lipoprotein (non-HDL) cholesterol
Measured as ratio to baseline
Time frame: From baseline (week 0) to week 52
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First Valley Medical Group
Lancaster, California, United States
RECRUITINGHeadlands Research CTR Lincoln
Lincoln, California, United States
RECRUITINGTorrance Clin Res Inst, Inc.
Lomita, California, United States
RECRUITINGPacific Clinical Studies
Los Alamitos, California, United States
RECRUITINGVAGLAHS Clinical Research Center (CRC)
Los Angeles, California, United States
NOT_YET_RECRUITINGValley Clinical Trials, Inc.
Northridge, California, United States
RECRUITING...and 320 more locations