| Outcome Measures: |
Primary: Change in Glycated Haemoglobin (HbA1c) [Percentage Point (%-Point)], Change in HbA1c from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of 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, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i., From baseline (Visit 2) to week 26 (Visit 28)|Change in HbA1c [Millimoles/Mole (mmol/Mol)], Change in HbA1c from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of 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, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i., From baseline (Visit 2) to week 26 (Visit 28) | Secondary: Change in Fasting Plasma Glucose, Change in fasting plasma glucose from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of 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, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i., From baseline (Visit 2) to week 26 (Visit 28)|9-point Profile (Individual SMPG Values), Participants measured their plasma glucose (PG) levels using blood glucose meters (as plasma equivalent values of capillary whole blood glucose) at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 9-point SMPG values after 26 weeks are presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of 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, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i., Week 26 (Visit 28)|Change in Mean of the 9-point Profile, Defined as the Area Under the Profile Divided by Measurement Time, Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of 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, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i., From baseline (Visit 2) to week 26 (Visit 28)|Fluctuations of the 9-point Profile (Defined as the Integrated Absolute Distance From the Mean Profile Value Divided by Measurement Time)., Participants measured their plasma glucose (PG) levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Presented fluctuation in 9-point SMPG profile is the integrated absolute distance from the mean profile value divided by measurement time and is calculated using the trapezoidal method. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of 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, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i., Week 26 (Visit 28)|Fasting C-peptide, Fasting C-peptide at week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of 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, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i., At week 26 (Visit 28)|Change in Body Weight, Change in body weight from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of 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, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i., From baseline (Visit 2) to week 26 (Visit 28)|Weekly Dose of Insulin 287 and Weekly Dose of Insulin Glargine, Weekly dose of insulin 287 and weekly dose of glargine at week 25 and week 26 are presented.The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of 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, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i., week 25 (Visit 27) and 26 (Visit 28)|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 endpoint was evaluated based on the data from on-treatment period, starting at the date of first dose of trial product, and ending at follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin., From baseline (Visit 2) to week 31 (Visit 30)|Number of Hypoglycaemic Alert Episodes (Level 1) (≥3.0 and <3.9 mmol/L (≥54 and <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 with plasma glucose value of equal to or above (\>=) 3.0 and less than (\<) 3.9 mmol/L (\>= 54 and \< 70 mg/dL) confirmed by BG meter. Number of hypoglycaemic alert episodes (level 1) that occurred from week 0 to week 26 are presented., From baseline (Visit 2) to week 26 (Visit 28)|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<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 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 occurred from week 0 to week 26 are presented., From baseline (Visit 2) to week 26 (Visit 28)|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 week 0 to week 26 are presented., From baseline (Visit 2) to week 26 (Visit 28)|Change in Anti-insulin 287 Antibody Titres, Samples from the insulin 287 arm of the study were analysed for anti-insulin 287 antibodies. Confirmed anti-insulin 287 antibody positive samples had an antibody titre value determined. The endpoint was evaluated based on the data from in-trial period, starting at randomisation, and ending at the last direct participant-site contact, or when participant withdrew their informed consent, or the last participant-investigator contact for participants lost to follow-up, or death., From baseline (Visit 2) to week 31 (Visit 30)|Change in Cross-reactive Anti-human Insulin Antibody Status (Positive/Negative), Anti-insulin 287 or glargine antibodies were classified as negative if % B/T was below a certain cut point. Samples positive for anti-insulin 287 or glargine antibodies were further tested for cross-reactivity to endogenous insulin. Samples not further tested are categorised as not applicable (NA). Unknown refers to samples with insufficient volume to perform analysis. The endpoint was evaluated based on the data from in-trial period, starting at randomisation, and ending at the last direct participant-site contact, or when participant withdrew their informed consent, or the last participant-investigator contact for participants lost to follow-up, or death., From baseline (Visit 2) to week 31 (Visit 30)|Change in Anti-insulin 287 Antibody Level, Change in anti-insulin 287 antibodies level is not assessed because change in anti-insulin 287 antibody titres is a more meaningful way of describing the change in antibody levels. The results for change in anti-insulin 287 antibody titres are reported as a separate endpoint., From baseline (Visit 2) to week 31 (Visit 30)
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| Locations: |
Novo Nordisk Investigational Site, Lancaster, California, 93534, United States|Novo Nordisk Investigational Site, Ventura, California, 93003, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89128, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28277, United States|Novo Nordisk Investigational Site, Whiteville, North Carolina, 28472, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Austin, Texas, 78731, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, 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, Halifax, Nova Scotia, B3H 1V7, 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, Sarnia, Ontario, N7T 4X3, Canada|Novo Nordisk Investigational Site, St-Marc-des-Carrières, Quebec, G0A 4B0, Canada|Novo Nordisk Investigational Site, Brno, 62500, Czechia|Novo Nordisk Investigational Site, Pardubice, 530 02, Czechia|Novo Nordisk Investigational Site, Praha 1, 110 00, Czechia|Novo Nordisk Investigational Site, Praha 4, 149 00, Czechia|Novo Nordisk Investigational Site, Praha 5, 150 00, Czechia|Novo Nordisk Investigational Site, Praha 8, 181 00, Czechia|Novo Nordisk Investigational Site, Praha, 128 08, Czechia|Novo Nordisk Investigational Site, Rakovník, 269 01, Czechia|Novo Nordisk Investigational Site, Slaný, 27401, Czechia|Novo Nordisk Investigational Site, Athens, 115 25, Greece|Novo Nordisk Investigational Site, Athens, GR-11527, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-54636, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-54642, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-57010, Greece|Novo Nordisk Investigational Site, Bialystok, 15-404, Poland|Novo Nordisk Investigational Site, Gdansk, 80-546, Poland|Novo Nordisk Investigational Site, Lodz, 90-132, Poland|Novo Nordisk Investigational Site, Poznan, 61-251, Poland|Novo Nordisk Investigational Site, Warsaw, 00-465, Poland|Novo Nordisk Investigational Site, Wierzchoslawice, 33-122, Poland|Novo Nordisk Investigational Site, Bratislava, 821 02, Slovakia|Novo Nordisk Investigational Site, Bratislava, 851 01, Slovakia|Novo Nordisk Investigational Site, Kosice, 040 01, Slovakia|Novo Nordisk Investigational Site, Moldava nad Bodvou, 045 01, Slovakia|Novo Nordisk Investigational Site, Sahy, 93601, Slovakia|Novo Nordisk Investigational Site, Trencin, 91101, Slovakia|Novo Nordisk Investigational Site, Koper, SI-6000, Slovenia|Novo Nordisk Investigational Site, Ljubljana, SI-1000, Slovenia
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