This trial is conducted in Africa and Asia. The aim of the trial is to compare patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in type 2 diabetes patients uncontrolled on NPH insulin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Dose individually adjusted by the subjects themselves according to the titration algorithm every second week. Administered subcutaneously (s.c., under the skin) twice daily.
Dose individually adjusted according to the directions given by the investigator. Administered subcutaneously (s.c., under the skin) twice daily.
Novo Nordisk Investigational Site
Alexandria, Egypt
Novo Nordisk Investigational Site
Banī Suwayf, Egypt
Novo Nordisk Investigational Site
Cairo, Egypt
Change in HbA1c From Baseline
Change in HbA1c (%) from baseline to the end of the treatment period.
Time frame: Week 0, week 20
Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline
Change in FPG (laboratory values) from baseline to the end of the treatment period
Time frame: Week 0, week 20
Number of Hypoglycaemic Episodes During the Trial From Baseline
The number of hypoglycaemic episodes (a blood glucose level of approximately 2.8 mmol/L \[50 mg/dL\] or plasma glucose level 3.1 mmol/L \[56 mg/dL\]) during the trial.
Time frame: Week 20
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)
Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included an overall score as well the subscale scores (daily life, diabetes management, compliance and psychological health). The scores were transformed to a 0-100 scale with higher scores indicating a better health state.
Time frame: Week 0, week 20
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden
Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included a subscale score -treatment burden. The scores were transformed to a 0-100 scale with higher scores indicating a better health state.
Time frame: Week 0, week 20
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Novo Nordisk Investigational Site
Bandung, Indonesia
Novo Nordisk Investigational Site
Malang, Indonesia
Novo Nordisk Investigational Site
Casablanca, Morocco
Novo Nordisk Investigational Site
Marrakesh, Morocco
Novo Nordisk Investigational Site
Jeddah, Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, Saudi Arabia
...and 5 more locations