Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics

January 19, 2017 updated by: Novo Nordisk A/S

A Trial Investigating the Hypoglycaemic Response to NN1250 in Subjects With Type 1 Diabetes

This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.

The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

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

  • Austria
      • Graz, Austria, 8010
        • Novo Nordisk Investigational Site

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index 18.0-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)

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
Experimental: IDeg
Drug: insulin degludec
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
Experimental: IGlar
Drug: insulin glargine
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration
Time Frame: Within 0-46 hours after last trial product administration
Within 0-46 hours after last trial product administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose
Time Frame: Within 0-46 hours after last trial product administration
Within 0-46 hours after last trial product administration
Time from start of hypoglycaemic induction until each level of plasma glucose is reached
Time Frame: Within 0-46 hours after last trial product administration
Within 0-46 hours after last trial product administration
Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L
Time Frame: Within 0-46 hours after last trial product administration
Within 0-46 hours after last trial product administration
Hypoglycaemic symptoms score during recovery from hypoglycaemia
Time Frame: Within 0-46 hours after last trial product administration
Within 0-46 hours after last trial product administration

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.

General Publications

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

October 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-3538
  • U1111-1111-8843 (Other Identifier: WHO)
  • 2008-008356-16 (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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