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Clinical Trial Details

Trial ID: L6654
Source ID: NCT04262661
Associated Drug: Nnc0472-0147
Title: A Study to Look at How Safe NNC0472-0147 is in Healthy People and in People With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Healthy Volunteers|Diabetes Mellitus, Type 2
Interventions: DRUG: NNC0472-0147|DRUG: insulin glargine|DRUG: Placebo (NNC0472-0147)
Outcome Measures: Primary: Part 1: Number of treatment emergent adverse events, Number of events, From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)|Part 2: Number of treatment emergent adverse events, Number of events, From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14) | Secondary: Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL), Number of episodes, From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)|Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL), Number of episodes, From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)|Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL), Number of episodes, From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)|Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL), Number of episodes, From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)|Number of severe hypoglycaemic episodes (level 3), Number of episodes, From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)|Number of severe hypoglycaemic episodes (level 3), Number of episodes, From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)|Area under the serum NNC0472-0147 concentration-time curve after a single dose, pmol\*h/L, From 0 hours until infinity after a single IMP administration at day 1 (visit 2).|Maximum observed serum NNC0472-0147 concentration after a single dose, pmol/L, From 0 hours until last measurement time after a single IMP administration at day 1 (visit 2)|Area under the serum NNC0472-0147 concentration-time curve during one dosing interval at steady state, pmol\*h/L, From 0 to 24 hours after last multiple IMP administration at day 14 (visit 9)|Maximum observed serum NNC0472-0147 concentration at steady state, pmol/L, From 0 to 24 hours after last multiple IMP administration at day 14 (visit 9)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-03-02
Completion Date: 2020-09-25
Results First Posted:
Last Update Posted: 2022-09-28
Locations: Novo Nordisk Investigational Site, Mainz, 55116, Germany|Novo Nordisk Investigational Site, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT04262661