| Outcome Measures: |
Primary: Glycosylated Haemoglobin (HbA1c), Estimated mean difference in HbA1c after 50 weeks of treatment, Week 50 | Secondary: Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment, Observed mean change from baseline in HbA1c at Week 14 (visit 11), Week 0, Week 14|Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment, Observed mean change in from baseline in HbA1c at Week 26 (visit 18), Week 0, Week 26|Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment, Observed mean change from baseline in HbA1c at Week 38 (visit 25), Week 0, Week 38|Change in Glycosylated Haemoglobin (HbA1c) at Week 50, Observed mean change from baseline in HbA1c at Week 50 (visit 32), Week 0, Week 50|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment, Number of subjects achieving HbA1c below 7.0% after 14 weeks of treatment (visit 11), Week 14|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment, Number of subjects achieving HbA1c below 7.0% after 26 weeks of treatment (visit 18), Week 26|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment, Number of subjects achieving HbA1c below 7.0% after 38 weeks of treatment (visit 25), Week 38|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment, Number of subjects achieving HbA1c below 7.0% after 50 weeks of treatment (visit 32), Week 50|Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment, Observed overall mean of PG increment after 14 weeks of treatment (Visit 11). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}, Week 14|Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment, Observed overall mean of PG increment after 26 weeks of treatment (visit 18). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}, Week 26|Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment, Observed overall mean of PG increment after 38 weeks of treatment (visit 25). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}., Week 38|Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment, Observed overall mean of PG increment after 50 weeks of treatment (visit 32). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}., Week 50|Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment, Observed overall mean of 8-point PG profile after 14 weeks of treatment (visit 11), Week 14|Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment, Observed overall mean of 8-point PG profile after 26 weeks of treatment (visit 18), Week 26|Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment, Observed overall mean of 8-point PG profile after 38 weeks of treatment (visit 25), Week 38|Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment, Observed overall mean of 8-point PG profile after 50 weeks of treatment (visit 32), Week 50
|
| Locations: |
Novo Nordisk Investigational Site, Ain Témouchent, 46000, Algeria|Novo Nordisk Investigational Site, Alger, 16000, Algeria|Novo Nordisk Investigational Site, Algiers, 16000, Algeria|Novo Nordisk Investigational Site, Constantine, 25000, Algeria|Novo Nordisk Investigational Site, Oran, 31000, Algeria|Novo Nordisk Investigational Site, Setif, 19000, Algeria|Novo Nordisk Investigational Site, Sidi Bel Abbes, 22000, Algeria|Novo Nordisk Investigational Site, Alexandria, 21131, Egypt|Novo Nordisk Investigational Site, Casablanca, 20000, Morocco|Novo Nordisk Investigational Site, Port Elizabeth, Eastern Cape, 6014, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1812, South Africa|Novo Nordisk Investigational Site, Pretoria, Gauteng, 0002, South Africa|Novo Nordisk Investigational Site, Pretoria, Gauteng, 0083, South Africa|Novo Nordisk Investigational Site, Vaderbijlpark, Gauteng, 1900, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4170, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4450, South Africa|Novo Nordisk Investigational Site, Kimberly, Northern Cape, 8301, South Africa|Novo Nordisk Investigational Site, Cape Town, Western Cape, 7945, South Africa|Novo Nordisk Investigational Site, Sandton, 2146, South Africa|Novo Nordisk Investigational Site, Tunisia, 1053, Tunisia
|
