Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes

October 16, 2015 updated by: Novo Nordisk A/S

A Randomised, Double-Blind, Single Dose, Six-Period Cross-over Dose Response Trial Comparing the Pharmacodynamics and Pharmacokinetics of Insulin 454 With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results
  • Specific inclusion criteria for subject with type 1 diabetes:
  • Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening
  • Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
  • Specific inclusion criteria for subject with type 2 diabetes:
  • Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening
  • Treated with insulin for the past 3 months prior to screening
  • Body Mass Index (BMI) between 22.0 and 35.0 kg/ m^2 (both inclusive)

Exclusion Criteria:

  • Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator.
  • Subject with a history of or presence of cancer
  • Any condition that the Investigator and/or Sponsor feels would interfere with study
  • Specific exclusion criteria for subject with type 2 diabetes:
  • Therapy with oral antidiabetic drugs within the past 3 months prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Insulin glargine
Drug: insulin glargine
Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.
Experimental: Insulin degludec
Drug: insulin degludec
Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the glucose infusion rate curve
Time Frame: 0-24 hours after dosing
0-24 hours after dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the insulin degludec/insulin glargine curve
Time Frame: 0-96 hours after dosing
0-96 hours after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

May 27, 2013

First Submitted That Met QC Criteria

May 27, 2013

First Posted (Estimate)

May 30, 2013

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

October 16, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-1719
  • 2006-001915-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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