| Outcome Measures: |
Primary: Percentage of Time in Target Range (TIR) 3.9-10.0 Millimoles Per Liter (mmol/L) (70-180 Milligrams Per Deciliter (mg/dL) Measured Using CGM (Continuous Glucose Monitoring), The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication). The endpoint is based on data recorded by CGM system. It was required that at least 70% of the planned CGM measurements during weeks 15-16 were available for endpoint data to be included in the analysis., During the last 2 weeks of treatment (week 15 and 16) | Secondary: Change in HbA1c (Glycated Haemoglobin), Estimated mean change in HbA1c from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication)., From baseline week 0 (visit 2) to week 16 (visit 18)|Change in Fasting Plasma Glucose (FPG), Estimated mean change in FPG from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication)., From baseline week 0 (visit 2) to week 16 (visit 18)|Change in Body Weight, Estimated mean change in body weight from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication)., From baseline week 0 (visit 2) to week 16 (visit 18)|Weekly Insulin Dose, Estimated mean average weekly insulin dose during the last 2 weeks of treatment is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was considered exposed to trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication)., During the last 2 weeks of treatment (week 15 and 16)|Number of Treatment Emergent Adverse Events (TEAEs), A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period was the time period from first dose of trial product (week 0, visit 2) until the follow-up visit (week 21, visit 20) or the last date on trial product + 5 weeks for once daily insulin and +6 weeks for once weekly insulin., From baseline week 0 (visit 2) to week 21 (visit 20)|Number of Severe Hypoglycaemic Episodes (Level 3), Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of severe hypoglycaemic episodes that occurred from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) are presented., From baseline week 0 (visit 2) to week 16 (visit 18)|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter) or Severe Hypoglycaemic Episodes (Level 3), Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG) meter or severe hypoglycaemic episodes (level 3) that occured from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) are presented., From baseline week 0 (visit 2) to week 16 (visit 18)|Number of Hypoglycaemic Alert Episodes (Level 1) (Greater Than or Equal to 3.0 and Below 3.9 mmol/L (Greater Than or Equal to 54 and Below 70 mg/dL), Confirmed by Blood Glucose (BG) Meter), Hypoglycaemia alert value (level 1) was defined as episodes that were sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy with plasma glucose value of equal to or above (\>=) 3.0 and \< 3.9 mmol/L (\>= 54 and \< 70 mg/dL) confirmed by BG meter. Number of hypoglycaemic alert episodes (level 1) that occured from baseline (week 0, visit 2) to end of treatment (week 16, visit 18) are presented., From baseline week 0 (visit 2) to week 16 (visit 18)
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| Locations: |
Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Lancaster, California, 93534, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Statesboro, Georgia, 30461, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89128, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37203, United States|Novo Nordisk Investigational Site, Austin, Texas, 78731, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-9302, United States|Novo Nordisk Investigational Site, Schertz, Texas, 78154, United States|Novo Nordisk Investigational Site, Karlovac, 47000, Croatia|Novo Nordisk Investigational Site, Osijek, 31 000, Croatia|Novo Nordisk Investigational Site, Rijeka, 51 000, Croatia|Novo Nordisk Investigational Site, Varazdin, 42 000, Croatia|Novo Nordisk Investigational Site, Bad Mergentheim, 97980, Germany|Novo Nordisk Investigational Site, Essen, 45136, Germany|Novo Nordisk Investigational Site, Falkensee, 14612, Germany|Novo Nordisk Investigational Site, Friedrichsthal, 66299, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Oldenburg I. Holst, 23758, Germany|Novo Nordisk Investigational Site, Pohlheim, 35415, Germany|Novo Nordisk Investigational Site, Saint Ingbert-Oberwürzbach, 66386, Germany|Novo Nordisk Investigational Site, Kaposvár, 7400, Hungary|Novo Nordisk Investigational Site, Szeged, H-6725, Hungary|Novo Nordisk Investigational Site, Zalaegerszeg, 8900, Hungary|Novo Nordisk Investigational Site, Bialystok, 15-435, Poland|Novo Nordisk Investigational Site, Lublin, 20-538, Poland|Novo Nordisk Investigational Site, Radom, 26-600, Poland|Novo Nordisk Investigational Site, Tomaszow Mazowiecki, 97-200, Poland|Novo Nordisk Investigational Site, Warszawa, 02-507, Poland|Novo Nordisk Investigational Site, Banska Bystrica, 97401, Slovakia|Novo Nordisk Investigational Site, Kosice, 040 01, Slovakia|Novo Nordisk Investigational Site, Nitra, 94911, Slovakia|Novo Nordisk Investigational Site, Rimavska Sobota, 97901, Slovakia|Novo Nordisk Investigational Site, Roznava, 04801, Slovakia|Novo Nordisk Investigational Site, Velky Meder, 93201, Slovakia|Novo Nordisk Investigational Site, Baracaldo, 48903, Spain|Novo Nordisk Investigational Site, La Coruña, 15006, Spain|Novo Nordisk Investigational Site, La Roca del Vallés, 08430, Spain|Novo Nordisk Investigational Site, Vic (Barcelona), 08500, Spain
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