TN01 Screening and Monitoring
Protocol ID: TN01 Screening and Monitoring: ClinicalTrials.gov # NCT000972
Official Title: Natural History Study of the Development of Type 1 Diabetes (Pathway to Prevention Study
PI Name: Andrew Muir, MD
Lead CRC: Amber Antich, CRC II
Condition or Disease: Diabetes Mellitus, Type 1
Brief Summary: Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. This study has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM.
Study Type/Primary Purpose: Observational/ Prospective/ Monitoring
Study Status: Recruiting
TN22 Hydroxychloroquine
Protocol ID: TN22 Hydroxychloroquine: ClinicalTrials.gov # NCT03428945
Official Title: Hydroxychloroquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At-risk for Type 1 Diabetes Mellitus (T1D)
PI Name: Andrew Muir, MD
Lead CRC: Lynette Gonzalez, CRC I
Condition or Disease: Diabetes Mellitus, Type 1
Brief Summary: The purpose of this study is to test a medication, called hydroxychloroquine (HCQ) to assess safety and effectiveness to prevent individuals at risk of T1D from progressing to type 1 diabetes.
Study Type/Primary Purpose: Interventional/ Prevention
Study Status: Closed
TN16 LIFT
Protocol ID: TN16 LIFT
Official Title: Long Term Investigative Follow‐Up In Trialnet (LIFT)
PI Name: Andrew Muir, MD
Lead CRC: Amber Antich, CRC II
Condition or Disease: Diabetes Mellitus, Type 1
Brief Summary: The purpose of this study is to evaluate the long term effects of participation in TrialNet studies.
Study Type/Primary Purpose: Descriptive
Study Status: Recruiting
TN18 Abatacept Prevention
Protocol ID: TN18 Abatacept Prevention: ClinicalTrials.gov # NCT01773707
Official Title: CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1 Diabetes
PI Name: Andrew Muir, MD
Lead CRC: Xiaomiao Lan-Pidhainy, PhD, RN
Condition or Disease: Diabetes Mellitus, Type 1
Brief Summary: The purpose of this study is to assess the safety, efficacy, and mode of action of Abatacept to prevent Abnormal Glucose Tolerance (AGT) and T1DM. The primary objective is to determine whether intervention with Abatacept will prevent or delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of patients with T1DM.
Study Type/Primary Purpose: Interventional/ Prevention
Study Status: Closed
TN 27
Protocol ID: TN 27
Official Title: TOPPLE T1D Study – Tolerance using Plasmid: A Phase 1 multiple ascending dose trial investigating safety, tolerability and pharmacokinetics of NNC0361-0041 administered subcutaneously to patients with type 1 diabetes mellitus
PI Name: Andrew Muir, MD
Lead CRC: Xiaomiao Lan-Pidhainy, PhD, RN
Condition or Disease: Type 1 Diabetes
Brief Summary: The trial will investigate the safety, tolerability and explore PK as well as target engagement properties following once weekly subcutaneous doses of plasmid NNC0361-0041 for 12 weeks in patients within 48 months of diagnosis of T1D.
Study Type/Primary Purpose: Intervention
Study Status: Recruiting
Endocrine Autoimmunity
Protocol ID: Endocrine Autoimmunity
Official Title: Immune Function during Various Stages of Type 1 Diabetes: Autoimmunity, Genetics and Immune Markers
PI Name: Andrew Muir, MD
Lead CRC: Amber Antich, CRC II
Condition or Disease: General Population
Brief Summary: To collect and store blood samples on individuals with Type 1 diabetes (T1DM) and Healthy Individuals for genetic and immune testing.
Study Status: Recruiting
Afrezza ® INHALE-1 Study in Pediatrics (INHALE-1)
Official Title: INHALE-1: A 26-week Primary Treatment Phase, With 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza ® Versus Rapid-acting Insulin Analog Injections, Both in Combination With a Basal Insulin, in Pediatric Subjects With Type 1 or Type 2 Diabetes Mellitus
PI Name: Kristina Cossen, MD
Lead CRC: Amber Antich, CRC II
Condition or Disease: Type 1 or Type 2 diabetes mellitus in pediatrics
Brief Summary: INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart or insulin lispro in combination with a basal insulin (i.e., the Rapid-acting Insulin Analog [RAA] injection group) in pediatric subjects with type 1 or type 2 diabetes mellitus. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), all subjects will enter a treatment extension where subjects will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza.
Study Status: Recruiting