| Outcome Measures: |
Primary: Change in Glycosylated Haemoglobin A1c (HbA1c), Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)., week 0, week 16 | Secondary: Change in Body Weight, Change in body weight from baseline (week 0) to 16 weeks (end of treatment), week 0, week 16|Change in Self-measured Fasting Plasma Glucose, Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary., week 0, week 16|7-point Self-measured Plasma Glucose Profiles, Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16)., week 0, 8, 12 and 16|Change in Beta-cell Function, Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5)., week 0, week 16|Change in Fasting Lipid Profile, Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on: * Total Cholesterol (TC) * Low-density Lipoprotein-cholesterol (LDL-C) * Very Low-density Lipoprotein-cholesterol (VLDL-C) * High-density Lipoprotein-cholesterol (HDL-C) * Triglyceride (TG) * Free Fatty Acid (FFA), week 0, week 16|Change in Fasting Lipid Profile, APO-B, Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment)., week 0, week 16|Hypoglycaemic Episodes, Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L., weeks 0-16
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| Locations: |
Novo Nordisk Investigational Site, Beijing, Beijing, 100029, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100730, China|Novo Nordisk Investigational Site, Chongqing, Chongqing, 400010, China|Novo Nordisk Investigational Site, Fuzhou, Fujian, 350025, China|Novo Nordisk Investigational Site, Harbin, Heilongjiang, 150001, China|Novo Nordisk Investigational Site, Harbin, Heilongjiang, 150086, China|Novo Nordisk Investigational Site, Wuhan, Hubei, 430022, China|Novo Nordisk Investigational Site, Nanjing, Jiangsu, 210008, China|Novo Nordisk Investigational Site, Suzhou, Jiangsu, 215004, China|Novo Nordisk Investigational Site, Wuxi, Jiangsu, 214023, China|Novo Nordisk Investigational Site, Xi'an, Shaanxi, 710032, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200003, China|Novo Nordisk Investigational Site, Hangzhou, Zhejiang, 310003, China|Novo Nordisk Investigational Site, Shenyang, 110001, China|Novo Nordisk Investigational Site, Tianjin, 300052, China|Novo Nordisk Investigational Site, Wuhan, 430060, China|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500 001, India|Novo Nordisk Investigational Site, Hyderbad, Andhra Pradesh, 500 012, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380 015, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560 017, India|Novo Nordisk Investigational Site, Cochin, Kerala, 695010, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400010, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411 037, India|Novo Nordisk Investigational Site, New Dehli, New Delhi, 110029, India|Novo Nordisk Investigational Site, Bhubaneswar, Orissa, 751019, India|Novo Nordisk Investigational Site, Jaipur, Rajasthan, 302006, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600 013, India|Novo Nordisk Investigational Site, Madurai, Tamil Nadu, 625 020, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700054, India|Novo Nordisk Investigational Site, Cochin, 682 304, India|Novo Nordisk Investigational Site, Ghaziabad, India|Novo Nordisk Investigational Site, Kolkata, 700017, India|Novo Nordisk Investigational Site, Kolkata, 700026, India|Novo Nordisk Investigational Site, Mumbai, 400 0067, India|Novo Nordisk Investigational Site, Mumbai, 400016, India|Novo Nordisk Investigational Site, New Delhi, 110017, India|Novo Nordisk Investigational Site, Patna, 800020, India|Novo Nordisk Investigational Site, Secunderabad, 500 003, India|Novo Nordisk Investigational Site, Trivandrum, 695029, India|Novo Nordisk Investigational Site, Visakhapatnam, 530002, India|Novo Nordisk Investigational Site, Goyang, 410-719, Korea, Republic of|Novo Nordisk Investigational Site, Incheon, 405-220, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 03080, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 08308, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 130-872, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 135-710, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 137-701, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 150-713, Korea, Republic of|Novo Nordisk Investigational Site, Sungnam, 463-707, Korea, Republic of|Novo Nordisk Investigational Site, Suwon, 16499, Korea, Republic of
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