• Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 [ Time Frame: week 0, week 52 ] [ Designated as safety issue: No ]
• Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104 [ Time Frame: week 0, week 104 ] [ Designated as safety issue: No ]

• Change in Body Weight at Week 52 [ Time Frame: week 0, week 52 ] [ Designated as safety issue: No ]
• Change in Body Weight at Week 104 [ Time Frame: week 0, week 104 ] [ Designated as safety issue: No ]
• Change in Fasting Plasma Glucose at Week 52 [ Time Frame: week 0, week 52 ] [ Designated as safety issue: No ]
• Change in Fasting Plasma Glucose at Week 104 [ Time Frame: week 0, week 104 ] [ Designated as safety issue: No ]
• Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52 [ Time Frame: week 0, week 52 ] [ Designated as safety issue: No ]
• Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104 [ Time Frame: week 0, week 104 ] [ Designated as safety issue: No ]
• Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52 [ Time Frame: week 0, week 52 ] [ Designated as safety issue: No ]
• Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104 [ Time Frame: week 0, week 104 ] [ Designated as safety issue: No ]
• Hypoglycaemic Episodes [ Time Frame: weeks 0-104 ] [ Designated as safety issue: Yes ]

• - Body Weight
• - Glycemic Control
• - Safety and Tolerability

This trial is conducted in North America (the United States of America (USA) and Mexico). The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. Two trial periods: A 52-week randomised, double-blind trial period followed by a 52-week open-label extension.

Trial dates:

Original trial: Start February 2006, finish November 2007 First extension: Start March 2007, finish November 2008

A second open label extension is registered, for internal administrative purposes only, as NN2211-3529.

• Drug: liraglutide
  1.8 mg for s.c. (under the skin) injection
  Other Name: NN2211
• Drug: glimepiride
  8 mg capsule
• Drug: liraglutide
  1.2 mg for s.c. (under the skin) injection
  Other Name: NN2211
• Drug: placebo
  Glimepiride placebo, 8mg capsule
• Drug: placebo
  Liraglutide placebo, 200 microL
• Drug: placebo
  Liraglutide placebo, 300 microL

• Lira 1.8: Experimental
  Liraglutide 1.8 mg once daily + glimepiride placebo
  Interventions:

  • Drug: liraglutide
  • Drug: placebo
• Lira 1.2: Experimental
  Liraglutide 1.2 mg once daily + glimepiride placebo
  Interventions:

  • Drug: liraglutide
  • Drug: placebo
• Glimepiride - 1: Active Comparator
  Glimepiride 8 mg once daily + liraglutide placebo
  Interventions:

  • Drug: glimepiride
  • Drug: placebo
• Glimepiride - 2: Active Comparator
  Glimepiride 8 mg once daily + liraglutide placebo
  Interventions:

  • Drug: glimepiride
  • Drug: placebo

Inclusion Criteria:

• Type 2 diabetes
• Treatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months
• Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive
• OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive
• Body Mass Index (BMI) less than or equal to 45 kg/m2

Exclusion Criteria:

• Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness
• Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)
• Any serious medical condition