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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: NNC 55-0414

Study type

Interventional

Funder types

Industry

Identifiers

NN414-1384

Details and patient eligibility

About

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

Enrollment

23 patients

Sex

All

Ages

40 to 74 years old

Volunteers

No Healthy Volunteers

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