Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. A seven day dose escalation study in subjects with type 2 diabetes.
Interventions
DRUGNNC 55-0414
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety and the tolerability of ascending multiple oral doses of NNC 55 0414 in patients with type 2 diabetes. | — |
Countries
Germany
Outcome results
None listed