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Clinical Trial Details

Trial ID: L3994
Source ID: NCT04575181
Associated Drug: Nnc0268-0965
Title: A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: NNC0268-0965|DRUG: Insulin glargine|DRUG: Placebo (NNC0268-0965)|DRUG: Placebo (insulin glargine)
Outcome Measures: Primary: Change in flow mediated dilation, Percent, From Visit 3B (week 0) to visit 30B (week 26) | Secondary: Change in pulse wave velocity, m/s, From Visit 3B (week 0) to visit 30B (week 26)|Change in leg blood flow, ml/100 ml/min, From Visit 3B (week 0) to visit 30B (week 26)|Change in retinal arteriolar dilation, Percent, From Visit 3A (week 0) to visit 30A (week|Relative change in liver fat percentage measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF), Ratio, From Visit 2 (week 0) to visit 29 (week 26)|Change in left ventricular ejection fraction, Percent, From Visit 2 (week 0) to visit 29 (week 26)|Change in glycosylated haemoglobin (HbA1c ), Percent, From Visit 3B (week 0) to visit 30B (week 26)|Change in body weight, kg, From Visit 3B (week 0) to visit 30B (week 26)|Change in body fat mass as measured by BOD POD (a method for determining the lean body mass), Percent, From Visit 3B (week 0) to visit 30B (week 26)|Relative change in rate of glucose disposal at short Insulin Tolerance Test, Ratio, From Visit 3B (week 0) to visit 30B (week 26)|Number of adverse events, Number of events, From Visit 3B (week 0) to visit 30B (week 26)|Number of severe hypoglycaemic episodes (level 3), Number of episodes, From Visit 3B (week 0) to visit 30B (week 26)|Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3), Number of episodes, From Visit 3B (week 0) to visit 30B (week 26)|Number of clinically significant hypoglycaemic episodes s (level 2) ((below 3.0 mmol/L (54 mg/dL), confirmed by BG meter), Number of episodes, From Visit 3B (week 0) to visit 30B (week 26)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 86
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-10-21
Completion Date: 2021-12-24
Results First Posted:
Last Update Posted: 2024-01-10
Locations: Profil GmbH & Co. KG, Mainz, 55116, Germany|Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT04575181