Clinical Trial Details
| Trial ID: | L4453 |
| Source ID: | NCT04279613 |
| Associated Drug: | Nnc0361-0041 |
| Title: | A Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0361-0041 |
| Acronym: | TOPPLE T1D |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type I Diabetes |
| Interventions: | DRUG: NNC0361-0041|OTHER: Placebo |
| Outcome Measures: | Primary: Adverse Events, Number of adverse events recorded during the on-treatment period, which is defined as from first treatment through visit 15 (or 5 weeks after last treatment for subjects not receiving all injections), 16 Weeks | Secondary: Change in the area under the plasma C-peptide concentration-time curve, Relative change in the area under the plasma C-peptide concentration-time curve from time 0 to 2 hours during MMTT from baseline to 3 months between groups, 3 months |
| Sponsor/Collaborators: | Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Collaborators: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 47 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2020-11-23 |
| Completion Date: | 2024-04-24 |
| Results First Posted: | |
| Last Update Posted: | 2024-05-13 |
| Locations: | Children's Hospital of Orange County, Orange, California, 92868, United States|University of California - San Francisco, San Francisco, California, 94143, United States|Stanford University, Stanford, California, 94305, United States|Barbara Davis Center at University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States|Yale University School of Medicine, New Haven, Connecticut, 06519, United States|University of Florida, Gainesville, Florida, 32610, United States|Emory Children's Center, Atlanta, Georgia, 30329, United States|Indiana University - Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|Regents of the University of Minnesota, Minneapolis, Minnesota, 55466, United States|The Children's Mercy Hospital, Kansas City, Missouri, 64108, United States|The Naomi Berrie Diabetes Center at Columbia University Medical Center, New York, New York, 10032, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States|Vanderbilt Eskind Diabetes Center, Nashville, Tennessee, 37232, United States|University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States |
| URL: | https://clinicaltrials.gov/show/NCT04279613 |
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