This study will evaluate the changes in glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus after receiving CT-868 for 16 weeks. The effectiveness and safety of CT-868 will be compared to placebo. All participants will continue with their standard diabetes care using either an insulin pump (CSII) or multiple daily injections (MDI). Alongside their designated treatment, participants will receive guidance on managing their diabetes, including monitoring blood glucose levels and diet and exercise recommendations. Treatment assignments, either CT-868 plus insulin or placebo plus insulin will be randomly determined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
111
CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.
The CT-868 pen injector is a multi-dose, single-participant, disposable pen.
The placebo pen injector is identical and contains the same ingredients except for CT-868.
John Muir Physician Network Clinical Research Center
Concord, California, United States
Headlands Research- AMCR
Escondido, California, United States
University of Colorado - Barbara Davis Center for Diabetes
Aurora, Colorado, United States
Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado, United States
Advent Health
Orlando, Florida, United States
Orlando Health Science Clinic, LLC
Orlando, Florida, United States
Innovative Research Institute
Port Charlotte, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Rocky Mountain Clinical Research, LLC- Idaho Falls, Idaho
Idaho Falls, Idaho, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
...and 12 more locations
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline
Time frame: at Day 1 to Week 16
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline
Time frame: at Day 1 to Weeks 4, 8, and 12
To assess the percentage of participants achieving HbA1c of <7.0%.
Time frame: at Week 16
To assess the percentage of participants achieving HbA1c of ≤6.5%.
Time frame: at Week 16
To assess the percentage of participants achieving HbA1c of <5.7%.
Time frame: at Week 16
Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo.
Time frame: at Day 1 to Week 16
Change in insulin doses from baseline when comparing CT-868 to placebo.
Time frame: at Day 1 to Weeks 8 and 16
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