A Study Looking Into the Effect of NNC 55-0414 in Subjects With Type 2 Diabetes

A Randomised, Double-blind, Placebo-controlled, Multiple Oral Dose, Dose Escalation Trial, Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 55-0414 in Patients With Type 2 Diabetes

This trial is conducted in Europe. A seven day dose escalation study in subjects with type 2 diabetes.

Inclusion Criteria:

• Type 2 diabetes
• Diet treatment only for at least two weeks
• Body mass index (BMI) between 22-34 kg/m2 inclusive
• HbA1C between 6.5-12.0% inclusive
• Fasting blood glucose (FBG) between 7.0-18.0 mmol/L inclusive
• Patients should be negative (lesser than 70 kU/l) for antibodies against glutamic acid decarboxylase (GAD)

Exclusion Criteria:

• Pharmacological treatment with medication or pancreatitis that the Investigator expected to interfere with blood glucose levels
• History of cancer or any clinically significant cardiovascular respiratory, hepatic, haematological, gastrointestinal, dermatological, venereal, neurological or psychiatric disorder as judged by the Investigator
• Impaired renal function, serum creatinine greater than 150µmol/L
• Patients, who were known to have serum hepatitis or who were carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or had a positive result to the test for HIV 1/2 antibodies
• Patients, who had received an investigational drug in the four months new chemical entity or licensed product preceding the start of dosing
• Patients, who had donated plasma or blood in the past month, or in excess of 500 mL in the past 12 weeks
• Patients who had a significant history of alcoholism or drug/chemical abuse