This trial is conducted in Africa. The aim of this clinical trial is to investigate the effect of 50 weeks of treatment with different intensified insulin administrations (all in combination with a fixed dose of metformin) on blood sugar control in subjects with type 2 diabetes inadequately controlled by oral anti-diabetic drugs (OADs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
403
Initial dose of 0.1 U/kg once daily, injected s.c. (under the skin).
Pending evaluation of HbA1c every 3 months, insulin aspart was added to the insulin detemir treatment (up to three does daily, injected s.c. (under the skin)
Initial dose of 0.1 U/kg once daily, injected s.c. (under the skin). Pending evaluation of HbA1c every 3 months, the dose will intensified up to 3 doses daily
Novo Nordisk Investigational Site
Ain Témouchent, Algeria
Novo Nordisk Investigational Site
Algiers, Algeria
Glycosylated Haemoglobin (HbA1c)
Estimated mean difference in HbA1c after 50 weeks of treatment
Time frame: Week 50
Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment
Observed mean change from baseline in HbA1c at Week 14 (visit 11)
Time frame: 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)
Time frame: 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)
Time frame: Week 0, Week 38
Change in Glycosylated Haemoglobin (HbA1c) at Week 50
Observed mean change from baseline in HbA1c at Week 50 (visit 32)
Time frame: 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)
Time frame: 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)
Time frame: Week 26
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment
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1000-2000 mg/day in combination with insulin treatment
Novo Nordisk Investigational Site
Constantine, Algeria
Novo Nordisk Investigational Site
Oran, Algeria
Novo Nordisk Investigational Site
Sétif, Algeria
Novo Nordisk Investigational Site
Sidi Bel Abbes, Algeria
Novo Nordisk Investigational Site
Alexandria, Egypt
Novo Nordisk Investigational Site
Casablanca, Morocco
Novo Nordisk Investigational Site
Port Elizabeth, Eastern Cape, South Africa
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa
...and 9 more locations
Number of subjects achieving HbA1c below 7.0% after 38 weeks of treatment (visit 25)
Time frame: 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)
Time frame: 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)}
Time frame: 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)}
Time frame: 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)}.
Time frame: 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)}.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Week 50