Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06334133

Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes

Led by vTv Therapeutics · Updated on 2026-04-24

150

Participants Needed

58

Research Sites

119 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.

CONDITIONS

Official Title

Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals 18 years and older
  • Diagnosed with Type 1 Diabetes Mellitus for at least 3 years
  • Experienced at least one Level 2 (glucose <54 mg/dL or <3 mmol/L confirmed) or Level 3 hypoglycemic event in the last 2 months
  • HbA1c value below 9.5% at screening
  • Using continuous subcutaneous insulin infusion (CSII) without closed-loop systems or multiple daily injections (MDI) for at least 6 months and willing to continue the same insulin treatment during the study
  • Using a continuous glucose monitoring (CGM) device for at least 3 months prior to screening
Not Eligible

You will not qualify if you...

  • Diagnosed with Type 2 Diabetes Mellitus, monogenic diabetes, maturity-onset diabetes of the young, or diabetes from secondary causes
  • Hospitalized for diabetic ketoacidosis (DKA) within 3 months prior to screening
  • Have uncontrolled hypothyroidism or hyperthyroidism
  • History of eating disorders such as anorexia, bulimia, or diabulimia within the last 2 years
  • Have active or untreated cancer or have been in remission for 5 years or less, except certain skin or cervical cancers
  • Used non-insulin anti-diabetic medications or weight loss drugs within 30 days prior to screening
  • Used hybrid closed-loop insulin systems or Do-It-Yourself looping within 30 days prior to screening and agree not to start during the study
  • Have an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2 at screening
  • Have uncontrolled high blood pressure prior to screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 58 locations

1

Scottsdale Clinical Trials

Scottsdale, Arizona, United States, 85260

Actively Recruiting

2

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States, 72205

Actively Recruiting

3

Advanced Metabolic Care & Research Institute, Inc. (AMCR)

Escondido, California, United States, 92025

Actively Recruiting

4

MD Studies, Inc

Fountain Valley, California, United States, 92078

Actively Recruiting

5

AME Clinical Research

Huntington Beach, California, United States, 92647

Actively Recruiting

6

310 Clinical Research

Inglewood, California, United States, 90301

Actively Recruiting

7

Scripps Whittier Diabetes Institute

La Jolla, California, United States, 92037

Actively Recruiting

8

Paradigm Clinical Research - Modesto

Modesto, California, United States, 95355

Actively Recruiting

9

Amicis Research Center

Northridge, California, United States, 91325

Actively Recruiting

10

Velocity Clinical Research

San Bernardino, California, United States, 92408

Actively Recruiting

11

Paradigm Clinical Research Centers LLC

San Diego, California, United States, 92108

Actively Recruiting

12

Acclaim Clinical Research

San Diego, California, United States, 92120

Actively Recruiting

13

The Lundquist Institute

Torrance, California, United States, 90502

Actively Recruiting

14

Focus Clinical Research

West Hills, California, United States, 91307

Actively Recruiting

15

Denver Endocrinology Diabetes and Thyroid Center

Englewood, Colorado, United States, 80113

Actively Recruiting

16

BayCare Health Systems

Clearwater, Florida, United States, 33756

Actively Recruiting

17

ALL Medical Research, LLC

Cooper City, Florida, United States, 33024

Withdrawn

18

Excellence Medical and Research

Miami Gardens, Florida, United States, 33169

Actively Recruiting

19

Metabolic Research Institute, Inc

West Palm Beach, Florida, United States, 33413

Actively Recruiting

20

Atlanta Diabetes Associates

Atlanta, Georgia, United States, 30318

Actively Recruiting

21

East Coast Institute for Research, LLC

Canton, Georgia, United States, 30114

Actively Recruiting

22

Centricity Research - Columbus

Columbus, Georgia, United States, 31904

Actively Recruiting

23

The Jones Center Clinical Research, LLC

Macon, Georgia, United States, 31210

Actively Recruiting

24

Endocrine Research Solutions, Inc

Roswell, Georgia, United States, 30076

Actively Recruiting

25

Paradigm Clinical Research

Boise, Idaho, United States, 83709

Actively Recruiting

26

DM Clinical Research

Indianapolis, Indiana, United States, 46254

Actively Recruiting

27

Accellacare - McFarland

Ames, Iowa, United States, 50010

Not Yet Recruiting

28

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States, 50265

Actively Recruiting

29

Johnson County Clin-Trials, LLC

Lenexa, Kansas, United States, 66219

Actively Recruiting

30

MedStar Good Samaritan Hospital

Baltimore, Maryland, United States, 21239

Actively Recruiting

31

Profound Research LLC

Farmington Hills, Michigan, United States, 48334

Actively Recruiting

32

Excel Clinical Research

Las Vegas, Nevada, United States, 89109

Actively Recruiting

33

Palm Research Center

Las Vegas, Nevada, United States, 89128

Actively Recruiting

34

Palm Research Center

Las Vegas, Nevada, United States, 89128

Actively Recruiting

35

Vector Clinical Trials

Reno, Nevada, United States, 89511

Actively Recruiting

36

AMC Community Endocrinology

Albany, New York, United States, 12203

Actively Recruiting

37

Jacobi Medical Center

The Bronx, New York, United States, 10461

Actively Recruiting

38

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

39

Javarra Inc.

Charlotte, North Carolina, United States, 28210

Actively Recruiting

40

Physician's East PA

Greenville, North Carolina, United States, 27834

Actively Recruiting

41

Lucas Research, Inc

Morehead City, North Carolina, United States, 28557

Actively Recruiting

42

Diabetes & Endocrinology Associates of Stark County, Inc

Canton, Ohio, United States, 44718

Actively Recruiting

43

John Muir Physician Network Clinical Research Center

Concord, Ohio, United States, 94520

Actively Recruiting

44

Velocity Clinical Research - Medford

Medford, Oregon, United States, 97504

Actively Recruiting

45

Velocity Clinical Research

Medford, Oregon, United States, 97504

Actively Recruiting

46

University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

47

Circle Clinical Research

Sioux Falls, South Dakota, United States, 57104

Actively Recruiting

48

Texas Diabetes and Endocrinology, P.A

Austin, Texas, United States, 78731

Actively Recruiting

49

Velocity Clinical Research - Dallas

Dallas, Texas, United States, 75230

Actively Recruiting

50

Tekton Research, LLC

McKinney, Texas, United States, 75069

Actively Recruiting

51

SMS Clinical Research LLC

Mesquite, Texas, United States, 75149

Actively Recruiting

52

Southern Endocrinology Associates PA

Mesquite, Texas, United States, 75149

Actively Recruiting

53

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, United States, 78229

Actively Recruiting

54

Consano Clinical Research

Shavano Park, Texas, United States, 78231

Actively Recruiting

55

Advanced Research Institute - Ogden

Ogden, Utah, United States, 84405

Withdrawn

56

Wasatch Clinical Research, LLC

Salt Lake City, Utah, United States, 84107

Actively Recruiting

57

University of Washington Diabetes Institute

Seattle, Washington, United States, 98109

Actively Recruiting

58

Citta Clinical Research, LLC

Spokane, Washington, United States, 99202

Actively Recruiting

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Research Team

J

Jennifer Freeman, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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