Purpose of this Study
This study includes several steps and lasts about 208 days in total. It begins with a screening period that lasts 28 days. During this time, you will have a full physical exam, your medical history will be reviewed, and you will have routine lab tests, a heart test called an electrocardiogram, and a sensor placed to check your blood sugar levels.
If you qualify and choose to join, you will be randomly assigned on the first dose day to receive either the study drug, called CNP-103, or a placebo, which does not contain any active medicine. The medicine or placebo will be given through a vein.
The treatment period lasts 90 days, followed by another 90 days of follow-up. During this time, doctors will check how your body reacts to the medicine and how safe it is.
Who Can Participate?
Eligibility
This study is for people who are between 12 and 35 years old. It includes boys and girls, but not women who are pregnant or breastfeeding. The people in the study must have been told they have type 1 diabetes within the last six months. They also need to be taking care of their diabetes, like using insulin or following a healthy eating plan. Their body must still be making a small amount of a substance called C-peptide, which helps show how well their body makes insulin.
Age Range
12-35
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a medicine called CNP-103 to see if it can safely help treat type 1 diabetes in young people between the ages of 12 and 35. These participants must have been recently told by their doctor that they have type 1 diabetes. The goal is to find out if the medicine can help their bodies and improve how they manage the disease.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
DEB01: A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 with Recent Onset Stage 3 Type 1 Diabetes
Principal Investigator
Jennifer
Green
Protocol Number
PRO00118482
NCT ID
NCT06783309
Phase
I/II
Enrollment Status
Pending Open to Enrollment