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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400283
First Posted: November 16, 2006
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.

Enrollment: 23
Actual Study Start Date: January 19, 2001
Study Completion Date: May 3, 2001
Primary Completion Date: May 3, 2001 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400283


Locations
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00400283     History of Changes
Other Study ID Numbers: NN414-1384
First Submitted: November 15, 2006
First Posted: November 16, 2006
Last Update Posted: February 24, 2017
Last Verified: February 2017

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