This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg/m2 or higher can join. The study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine. Depending on a person's diabetes treatment, a person will be assigned either to * Part A: healthy eating and physical activity * Part B: diabetes tablets (no injection of insulin) * Part C: injection of insulin (with or without diabetes tablets) Participants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week. You have a 2 in 3 chance of getting survodutide. During the study, participants continue their regular diabetes treatment. Participants are in the study for about 1 year and 2 months. During this time, they attend up to 12 visits at the site and receive at least 9 phone calls. Study doctors regularly test participants' blood sugar by checking their HbA1c values and other laboratory test results. The study doctor also regularly checks participants' health and takes note of any changes. For each study part, the results will be compared between the survodutide and the placebo group to see whether the treatment works.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
Placebo
Survodutide
Cahaba Research, Inc. - Trussville Location
Birmingham, Alabama, United States
NOT_YET_RECRUITINGMission Research Institute - Gilbert
Gilbert, Arizona, United States
NOT_YET_RECRUITINGHelios Clinical Research - Paradise Valley
Paradise Valley, Arizona, United States
NOT_YET_RECRUITINGArizona Liver Health - Peoria 85381
Peoria, Arizona, United States
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
Time frame: At baseline and Week 41.
Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53
Time frame: At baseline and Week 53.
Key secondary endpoint: Achievement of HbA1c <6.5% (yes/no) at Week 41
Time frame: At baseline and Week 41.
Achievement of HbA1c <5.7% (yes/no) at Week 41
Time frame: At Week 41.
Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53
Time frame: At baseline and Week 53.
Percent change in body weight (kg) from baseline to Week 53
Time frame: At baseline and Week 53.
Relative change in non-HDL (high-density lipoprotein) cholesterol from baseline to Week 53
Time frame: At baseline and Week 53.
Relative change in triglycerides from baseline to Week 53
Time frame: At baseline and Week 53.
Estimated glomerular filtration rate (CKD-EPIcr) slope of change from baseline to Week 53
CKD-EPIcr: Chronic Kidney Disease Epidemiology Collaboration creatinine equation
Time frame: At baseline and Week 53.
Relative change in urinary albumin-to-creatinine ratio (UACR) from baseline to Week 53 as a continuous variable
Time frame: At baseline and Week 53.
Absolute change in systolic blood pressure (SBP, mmHg) from baseline to Week 53
Time frame: At baseline and Week 53.
Part C: Absolute change in daily basal insulin dose from baseline to Week 53
Time frame: At baseline and Week 53.
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Helios Clinical Research - Phoenix
Phoenix, Arizona, United States
NOT_YET_RECRUITINGWoodland International Research Group, Inc.
Little Rock, Arkansas, United States
RECRUITINGSan Fernando Valley Health
Canoga Park, California, United States
NOT_YET_RECRUITINGJohn Muir Physician Network Clinical Research Center
Concord, California, United States
RECRUITINGNeighborhood Healthcare - Escondido
Escondido, California, United States
NOT_YET_RECRUITINGClinical Trials Research - Lincoln
Lincoln, California, United States
NOT_YET_RECRUITING...and 111 more locations