Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

• Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: week 36 ] [ Designated as safety issue: No ]
  Analysed for the full analysis set.
• Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: week 36 ] [ Designated as safety issue: No ]
  Measured for the Per Protocol analysis set.

• Hypoglycaemic Episodes [ Time Frame: Weeks 0-36 ] [ Designated as safety issue: No ]
  Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
• Biochemistry: Serum Alanine Aminotransferase [ Time Frame: week 36 ] [ Designated as safety issue: No ]
  Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.
• Haematology: Haemoglobin Measured in Blood [ Time Frame: week 36 ] [ Designated as safety issue: No ]
  Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.
• Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide [ Time Frame: week 36 ] [ Designated as safety issue: No ]
  High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.

• Adverse events
• Hypoglycaemic episodes
• Biochemistry
• Haematology
• CV risk markers

This trial is conducted in Europe, Africa and the United States of America (USA).

The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.

• Diabetes
• Diabetes Mellitus, Type 2

• Drug: insulin detemir
  Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)
• Drug: insulin aspart
  Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)
• Drug: insulin aspart
  Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)

• Experimental: Advanced
  Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
  Interventions:

  • Drug: insulin detemir
  • Drug: insulin aspart
• Active Comparator: Basic
  Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
  Interventions:

  • Drug: insulin detemir
  • Drug: insulin aspart

Inclusion Criteria:

• Type 2 diabetes mellitus for more than 6 months
• HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
• BMI (Body Mass Index) less than 40 kg/m2
• Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
• Treatment with one to 3 OADs

Exclusion Criteria:

• Known or suspected allergy to trial products or related products
• Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
• Previous participation in any trial including this for the last 6 months
• Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)