| Outcome Measures: |
Primary: Percentage of Time in Target Range 3.9-10.0 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 on treatment with 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) | Secondary: Change in Glycosylated Haemoglobin (HbA1c), Estimated mean change from baseline (week 0) in HbA1c at week 16 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 on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication)., From baseline week 0 (V2) to week 16 (V18)|Change in Fasting Plasma Glucose (FPG), Estimated mean change from baseline (week 0) in FPG at week 16 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 on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication)., From baseline week 0 (V2) to week 16 (V18)|Change in Body Weight, Estimated mean change from baseline (week 0) in body weight at week 16 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 on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication)., From baseline week 0 (V2) to week 16 (V18)|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 on treatment with 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), An adverse event(AE) is any untoward medical occurrence in a clinical trial subject administered or using a medicinal product, whether or not considered related to the medicinal product or usage.. 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 until the follow-up visit or the last date on trial product + 5 weeks for once daily insulin and +6 weeks for once weekly insulin. Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product., From baseline week 0 (V2) to week 21 (V20)|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 during weeks 0-16 are presented., From baseline week 0 (V2) to week 16 (V18)|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), 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 \<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 during weeks 0-16 are presented., From baseline week 0 (V2) to week 16 (V18)|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 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. Number of hypoglycaemic alert episodes (level 1) (equal to or above 3.0 and below 3.9 mmol/L (equal to or above 54 and below 70 mg/dL), confirmed by BG meter) that occured during weeks 0-16 are presented., From baseline week 0 (V2) to week 16 (V18)
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| Locations: |
Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Idaho Falls, Idaho, 83404-7596, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89148, United States|Novo Nordisk Investigational Site, Nashua, New Hampshire, 03063, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37203, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75226, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, 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, Renton, Washington, 98057, United States|Novo Nordisk Investigational Site, Edmonton, Alberta, T6G 2E1, Canada|Novo Nordisk Investigational Site, Surrey, British Columbia, V3Z 2N6, Canada|Novo Nordisk Investigational Site, Vancouver, British Columbia, V5Y 3W2, Canada|Novo Nordisk Investigational Site, Halifax, Nova Scotia, B3H 2Y9, Canada|Novo Nordisk Investigational Site, Brampton, Ontario, L6S 0C6, Canada|Novo Nordisk Investigational Site, Concord, Ontario, L4K 4M2, Canada|Novo Nordisk Investigational Site, Etobicoke, Ontario, M9R 4E1, Canada|Novo Nordisk Investigational Site, Hamilton, Ontario, L8M 1K7, Canada|Novo Nordisk Investigational Site, Markham, Ontario, L3P 7P2, Canada|Novo Nordisk Investigational Site, Sarnia, Ontario, N7T 4X3, Canada|Novo Nordisk Investigational Site, Broumov, 550 01, Czechia|Novo Nordisk Investigational Site, Holešov, 76901, Czechia|Novo Nordisk Investigational Site, Hranice, 75301, Czechia|Novo Nordisk Investigational Site, Trutnov, 541 01, Czechia|Novo Nordisk Investigational Site, Falkensee, 14612, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Ludwigshafen, 67059, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Oldenburg I. Holst, 23758, Germany|Novo Nordisk Investigational Site, Saint Ingbert-Oberwürzbach, 66386, Germany|Novo Nordisk Investigational Site, Bergamo, 24127, Italy|Novo Nordisk Investigational Site, Catanzaro, 88100, Italy|Novo Nordisk Investigational Site, Milano, 20122, Italy|Novo Nordisk Investigational Site, Milano, 20132, Italy|Novo Nordisk Investigational Site, Roma, 00161, Italy
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