Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes

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.
 
ClinicalTrials.gov Identifier: NCT01865318
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, under single-dose and steady-state conditions in male subjects with type 1 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin degludec Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Centre, Open-Label, Multiple Dose Trial Examining the Pharmacodynamic Characteristics of Insulin 454 Under Single-Dose and Steady-State Conditions in Male Subjects With Type 1 Diabetes
Study Start Date : September 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Part 1 (Once-daily dosing regimen, high concentration) Drug: insulin degludec
Administered subcutaneously (s.c., under the skin)

Experimental: Part 2 (Twice-daily dosing regimen, high concentration) Drug: insulin degludec
Administered subcutaneously (s.c., under the skin)

Experimental: Part 3 (Once-daily dosing regimen, low concentration) Drug: insulin degludec
Administered subcutaneously (s.c., under the skin)




Primary Outcome Measures :
  1. Area under the glucose infusion rate curve [ Time Frame: 0-24 hours after dosing ]

Secondary Outcome Measures :
  1. Maximum glucose infusion rate (GIRmax) [ Time Frame: 0-24 hours after dosing ]
  2. Time to maximum glucose infusion rate (tGIRmax) [ Time Frame: 0-24 hours after dosing ]
  3. Area under the serum insulin degludec curve [ Time Frame: 0-96 hours after dosing ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
  • Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
  • Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
  • Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results

Exclusion Criteria:

  • History of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
  • Participation in any other trials involving investigational products within 3 months preceding the start of dosing

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): NCT01865318


Locations
Layout table for location information
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01865318     History of Changes
Other Study ID Numbers: NN5401-1740
2006-002212-97 ( EudraCT Number )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs