The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes

• Maximal oxygen uptake (VO2peak) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  Changes in VO2peak from baseline to 16 weeks
• Body weight [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  Changes in body weight from baseline to 16 weeks evaluated by a full body DEXA scan
• Blood pressure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  Changes in blood pressure from baseline to 16 weeks
• Glycaemic control [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  Changes in overall glycaemic control parameters, insulin sensitivity and beta cell function evaluated by The Homeostasis Model Assessment (HOMA) and incretin hormones response
• Meal test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  The changes in the postprandial response of incretin hormones, insulin and glucose, glucagon and the microvascular blood flow will be evaluated. Changes in blood leves of triglycerides and cholesterol.
• Myocardial echocardiography [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

The objective of this study is to investigate the effects of physical training in patients with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®) in a 16-weeks double-blinded, randomized placebo-controlled clinical trial.

Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients when training is combined with liraglutide (Victoza®) treatment.

• Other: Training and liraglutide
• Other: Training and placebo

• Active Comparator: Training and liraglutide
  Treatment with both training and liraglutide for 16 weeks
  Intervention: Other: Training and liraglutide
• Placebo Comparator: Training and placebo
  Treatment wiht both training and placebo for 16 weeks
  Intervention: Other: Training and placebo

Inclusion Criteria:

• Informed oral and written consent
• Diagnosed with type 2 diabetes according to the criteria of the WHO
• HbA1C: 7-11% (doing treatment with diet and/or metformin)
• Age >18 years
• BMI >25 kg/m2 <40 kg/m2
• Negative islet cell antibodies (ICA) and glutamate decarboxylase 65 (GAD- 65) autoantibodies

Exclusion Criteria:

• Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures.
• Subjects treated with sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, insulin or glitazones
• Ongoing abuse of alcohol or narcotics
• Impaired hepatic function (liver transaminases >2 times upper normal limit)
• Impaired renal function (se-creatinine >150μM and/or albuminuria)
• Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
• Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg)
• Anaemia
• Any condition that the investigators feels would interfere with trial participation
• Receiving any investigational drug within the last 3 months