Status:
COMPLETED
A Study Looking Into the Effect of NNC 55-0414 in Subjects With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40-74 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. A seven day dose escalation study in subjects with type 2 diabetes.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2001
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00400283
Start Date
January 19 2001
End Date
May 3 2001
Last Update
February 24 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Berlin, Germany, 14050