NCT05794581

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

March 10, 2023

Last Update Submit

December 20, 2024

Conditions

Type 1 Diabetes

Keywords

Type 1 DiabetesObesityOverweight

Outcome Measures

Primary Outcomes (1)

  • To assess area under the curve (AUC) in glucose metabolism during MMTT

    Baseline up to 4 days

Secondary Outcomes (2)

  • To assess changes in continuous glucose monitoring (CGM) measures

    Baseline up to 4 days

  • Area under the acetaminophen concentration-time (AUC)

    0 - 300 minutes

Study Arms (3)

CT-868

EXPERIMENTAL

SC injection of CT-868 Intervention

Drug: CT-868

Placebo

PLACEBO COMPARATOR

SC injection of placebo matching CT-868 dose

Drug: Placebo

Victoza

ACTIVE COMPARATOR

SC injection of active comparator

Drug: Victoza

Interventions

CT-868DRUG

CT-868

CT-868
PlaceboDRUG

Placebo as SC Injection

Placebo
VictozaDRUG

Victoza as active comparator as SC Injection

Also known as: Liraglutide
Victoza

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant medical history
  • Uncontrolled diabetes
  • History of surgical treatment for weight loss
  • History of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmot Clinical Research Unit 101

Chula Vista, California, 91911, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1ObesityOverweight

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2023

First Posted

April 3, 2023

Study Start

March 21, 2023

Primary Completion

March 6, 2024

Study Completion

April 6, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)