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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00400283
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01-19
• Primary Completion: 2001-05-03
• Study Completion: 2001-05-03
• Study First Submitted: 2006-11-15
• Study First Submitted QC: 2006-11-15
• Study First Posted: 2006-11-16
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine the safety and the tolerability of ascending multiple oral doses of NNC 55 0414 in patients with type 2 diabetes.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Berlin, Germany