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

• Status: Completed
• Trial end date: 2001-05-03
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

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