A Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants with Type 1 Diabetes

What Was Tested

The trial (phase 1) is built around Liraglutide.

This study will be conducted primarily to evaluate the effects of CT-868 on glucose homeostasis in participants with Type 1 Diabetes Mellitus.

It had three arms (groups): CT-868 (experimental), Placebo (placebo comparator) and Victoza (active comparator).

SC injection of CT-868 Intervention.

SC injection of active comparator.

The registry classes the interventions as drug.

Who Took Part

The registry lists 32 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Female or male adults with Type 1 diabetes. Ages 18-65 years. Type 1 DM for at least 3 years. Using an insulin pump or multiple daily injections (MDI) for at least 3 months. BMI 25.0 - 35.0.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: uncontrolled diabetes; history of surgical treatment for weight loss; history of malignancy.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-03-21 with completion listed for 2024-03-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To assess area under the curve (AUC) in glucose metabolism during MMTT (time frame: Baseline up to 4 days).

It also tracked 2 secondary outcomes, for example To assess changes in continuous glucose monitoring (CGM) measures and Area under the acetaminophen concentration-time (AUC).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 32 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.