Effect of Different Insulin Administrations, All in Combination With Metformin, on Glycaemic Control in Subjects With Type 2 Diabetes Inadequately Controlled by Oral Anti-diabetic Drugs

Inclusion criteria

• Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
• Diagnosed type 2 diabetes (WHO 1999 criteria)
• Currently treated with suboptimal daily dose of OADs (mono or combination therapy) for at least 6 months
• Male or female age at least 18 years old
• HbA1c at least 7.0 % and maximum 11.0% for subjects treated with metformin mono-therapy, or maximum 10% for subjects treated with OAD combination therapy
• BMI maximum 40 kg/m^2
• Able and willing to perform self-monitoring of plasma glucose according to the protocol and to keep a diary
• Able and willing to be treated with up to 4 insulin injections per day

Exclusion criteria

• Known or suspected allergy to trial product(s) or related products
• Previous participation in this trial. Participation is defined as randomisation
• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
• Participated in another clinical trial and received an investigational drug within the last weeks prior to the present trial
• Impaired hepatic function defined as alanine aminotransferase (ALT) or alkaline phosphatase (ALP) at least 2.5 times upper referenced limit
• Impaired renal function defined as serum-creatinine at least 1.3 mg/dL (at least 115 mmol/L) for males and at least 1.2 mg/dL (at least 106 mmol/L) for females
• Subject has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (MI), arrhythmias or conduction delays on ECG, unstable angina, or decompensated heart failure (New York Heart Association class III and IV)
• Severe uncontrolled treated or untreated hypertension (sitting systolic blood pressure at least 180 mmHg or sitting diastolic blood pressure at least 100 mmHg)
• Proliferative retinopathy or macular oedema requiring acute treatment
• Metformin contraindications according to the package insert
• Current treatment with systemic corticosteroids
• Subject has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering study drug to the subject
• Current addiction to alcohol or other addictive substances as determined by the Investigator
• Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation in the study or use of the glucose monitor
• History of hypoglycaemic unawareness and/or two or more severe hypoglycaemic episodes in the past year as judged by the Investigator