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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00400283
First received: November 15, 2006
Last updated: June 28, 2012
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: NNC 55-0414
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Multiple Oral Dose, Dose Escalation Trial, Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 55-0414 in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • To determine the safety and the tolerability of ascending multiple oral doses of NNC 55 0414 in patients with type 2 diabetes. [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: January 2001
Study Completion Date: May 2001
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400283

Locations
Germany
Berlin, Germany, 14050
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Milan Zdravkovic, MD, Ph.D Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00400283     History of Changes
Other Study ID Numbers: NN414-1384
Study First Received: November 15, 2006
Last Updated: June 28, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014