Diabetes Mellitus, Type 1 Clinical Trial
— CATT1Official title:
Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes: A 52-Week Double-Blind, Randomized, Placebo-Controlled Phase 3 Study
This is a Phase 3 trial of cadisegliatin in participants with Type 1 Diabetes Mellitus.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | March 2026 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Individuals =18 years - Diagnosed T1DM with a minimum of 5 years since diagnosis - Has had at least 1 hypoglycemic event of Level 2 (glucose level <54 mg/dL or <3 mmol/L, [CGM or SMBG confirmed]) or Level 3 (defined as a severe hypoglycemia with altered mental state and/or physical status requiring assistance) in the last 2 months prior to Screening - HbA1c value of <9.5% at Screening - Is currently on CSII (closed-loop systems are prohibited) or is on MDI for at least 6 months prior to the Screening Visit and is willing to stay on same type of insulin treatment and the current mode of insulin administration (CSII or MDI injection treatments) for the duration of the study - Must have used a CGM device for at least 3 consecutive months prior to Screening Exclusion Criteria: - Has T2DM, monogenic diabetes, maturity-onset diabetes of the young, other unusual or rare forms of diabetes mellitus, or diabetes resulting from a secondary disease - Has been hospitalized for DKA within 3 months prior to Screening - Has uncontrolled hypothyroidism or hyperthyroidism - History of eating disorder within the last 2 years such as anorexia, bulimia, diabulimia or neglecting to give insulin to manipulate weight - Has an active or untreated malignancy, or has been in remission from malignancy for =5 years except well-treated basal cell or squamous cell skin cancer or cervical cancer in situ - Has used any of the following medications within the specified time periods - any non- insulin anti-diabetic therapies, e.g., sodium glucose cotransporter-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin, sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, or pramlintide within 90 days prior to the Screening or weight loss medications within 30 days prior to the Screening - Has used a hybrid closed-loop system (e.g., Medtronic 670G, Omnipod 5, or Tandem X2 with control IQ) or Do-It-Yourself looping within the last 1 month prior to the Screening Visit, and agrees to not start hybrid closed-loop systems or Do-It-Yourself looping during the study. - Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 utilizing the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening - Has persistent, uncontrolled hypertension prior to Screening |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
vTv Therapeutics |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in incidence of Level 2 or Level 3 hypoglycemia | Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo. | 52 weeks | |
Other | To assess the change in HbA1c | Change from baseline in HbA1c in participants on cadisegliatin vs placebo | 52 weeks | |
Other | To assess the effects of treatment on CGM-based metrics for glycemic control | To evaluate the change from baseline for time in, above or below target range of participants on cadisegliatin vs placebo | 52 weeks | |
Other | To assess the incidence of adverse events | Evaluation and comparison of the number of adverse events with cadisegliatin vs placebo during the study | 52 weeks | |
Other | To assess the effects of treatment on the incidence of diabetic ketoacidosis | Percentage of participants with incidence of diabetic ketoacidosis on cadisegliatin vs placebo | 52 weeks | |
Other | To assess the effects of treatment on insulin dosing | Change from baseline in basal, bolus and total insulin dosing | 52 weeks | |
Other | To assess the effects of treatment on body weight | Change from baseline in mean body weight | 52 weeks | |
Other | High sensitivity C-reactive protein | Change from baseline of biomarkers | 26 and 52 weeks | |
Other | N-terminal pro brain [or B-type] natriuretic peptide | Change from baseline of biomarkers | 26 and 52 weeks | |
Other | Urinary albumin excretion ratio | Change from baseline of biomarkers | 26 and 52 weeks | |
Other | Estimated glomerular filtration rate | Change from baseline of biomarkers | 26 and 52 weeks | |
Other | Gold hypoglycemia awareness score | Change from baseline in patient reported outcomes scores to assess the burden of hypoglycemia. Scale from 1 (always aware) to 7 (never aware). | 26 and 52 weeks | |
Other | Item 7 of Clarke hypoglycemia awareness scale | Change from baseline in patient reported outcomes scores to assess the burden of hypoglycemia. Scale from less than 40 mg/dL to 79mg/dL. | 26 and 52 weeks | |
Other | Snyder's 1-item quality of sleep questionnaire | Change from baseline in patient reported outcomes scores to assess the burden of hypoglycemia. Scale from 0 (terrible) to 10 (excellent). | 26 and 52 weeks | |
Other | World Health Organization-5 Well-Being Index | Change from baseline in patient reported outcomes scores to assess the burden of hypoglycemia. Ranges from not confident to very confident. | 26 and 52 weeks | |
Other | 8-item Diabetes Distress Scale (participant and partner or family member) | Change from baseline in PRO scores to assess the burden of hypoglycemia | 26 and 52 weeks | |
Other | Hypoglycemia Confidence Scale for participant and partner or family member | Change from baseline in PRO scores to assess the burden of hypoglycemia | 26 and 52 weeks | |
Other | 11-item/Short Form Hypoglycemia Fear Scale | Change from baseline in PRO scores to assess the burden of hypoglycemia | 26 and 52 weeks | |
Primary | Change in incidence of Level 2 or Level 3 hypoglycemia | Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo. | 26 weeks | |
Secondary | To assess the change in HbA1c | Change from baseline in HbA1c in participants on cadisegliatin vs placebo. | 26 weeks | |
Secondary | To assess the effects of treatment on CGM-based metrics for glycemic control | To evaluate the change from baseline for time in, above or below target range of participants on cadisegliatin vs placebo | 26 weeks | |
Secondary | To assess the effects of treatment on the incidence of diabetic ketoacidosis | Number of events of diabetic ketoacidosis participants on cadisegliatin vs placebo | 26 weeks | |
Secondary | To assess the effects of treatment on insulin dosing | Change from baseline in basal, bolus and total insulin dosing | 26 weeks | |
Secondary | To assess the effects of treatment on body weight | Change from baseline in mean body weight | 26 weeks | |
Secondary | To assess the incidence of adverse events | Evaluation and comparison of the number of adverse events with cadisegliatin vs placebo during the study | 26 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
Terminated |
NCT03605329 -
Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS
|
N/A | |
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Recruiting |
NCT06050642 -
Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
|
N/A | |
Completed |
NCT05107544 -
Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04443153 -
Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes
|
N/A | |
Completed |
NCT04569994 -
A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes
|
Phase 1 | |
Completed |
NCT04521634 -
Glycaemic Variability in Acute Stroke
|
||
Completed |
NCT04089462 -
Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study
|
N/A | |
Completed |
NCT03143816 -
Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study
|
Phase 4 | |
Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A | |
Completed |
NCT04042207 -
Diabeloop for Highly Unstable Type 1 Diabetes
|
N/A | |
Not yet recruiting |
NCT06068205 -
COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
|
||
Recruiting |
NCT05909800 -
Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes.
|
Phase 2 | |
Active, not recruiting |
NCT04974528 -
Afrezza® INHALE-1 Study in Pediatrics
|
Phase 3 | |
Completed |
NCT04530292 -
Home Intervention and Social Precariousness in Childhood Diabetes
|
N/A | |
Completed |
NCT05428943 -
OPT101 in Type 1 Diabetes Patients
|
Phase 1 | |
Recruiting |
NCT03988764 -
Monogenic Diabetes Misdiagnosed as Type 1
|
||
Completed |
NCT05597605 -
The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
|
N/A |