Comparison of Insulin Detemir and NPH With Respect to Lowering the Blood Sugar and Symptoms Experienced by Type 1 Diabetics During Hypoglycaemia

January 26, 2017 updated by: Novo Nordisk A/S

Trial Investigating the Hypoglycaemic Response to Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes

This trial is conducted in UK. The aim of this clinical trial is to investigate lowering the blood sugar and symptoms experienced during hypoglycaemia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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

  • United Kingdom
      • Guildford, United Kingdom, GU2 7XX
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed and dated informed consent obtained before any trial-related activities.
  • Type 1 diabetes
  • Treatment with insulin for minimum three months
  • Duration of diabetes for more than 12 months
  • Body Mass Index (BMI) less than 30 kg/m2
  • HbA1c equal to or greater than 10 % based on analysis from central laboratory

Exclusion Criteria:

  • Participation in any other clinical trial involving other investigational products within the last three months
  • Current treatment with insulin in a daily dose above 100 U
  • Episode of symptomatic hypoglycaemia, or a capillary plasma glucose value of less than 3.5 mmol/L in the past two weeks
  • Hypoglycaemic unawareness or severe autonomic neuropathy
  • Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors
  • Current treatment with oral antidiabetic drugs
  • Impaired hepatic function measured as ALAT of more than two times the upper reference limit
  • Impaired renal function measured as creatinine of more than 150 micromol/L (1.7 mg/dL)
  • Cardiac problems defined as decompensated heart failure (NYHA class III and IV) at any time and/or angina pectoris and/or myocardial infarction within the last 12 months
  • Known or suspected allergy to trial product or related products
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
  • Blood donation of more than 500 mL within the last three months
  • Any condition that the Investigator and/or the Sponsor feels would interfere with study participation or evaluation of results
  • Pregnancy or intention of becoming pregnant, breast-feeding or judged to be using inadequate contraceptive methods. Adequate contraceptive methods are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods
  • Previous participation in this trial

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration based on the Edinburgh Hypoglycaemia Scale: autonomic symptoms, neuroglycopenic symptoms and general malaise
Time Frame: From -40 min and until immediately before trial product administration
From -40 min and until immediately before 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

April 1, 2004

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

September 25, 2008

First Submitted That Met QC Criteria

September 25, 2008

First Posted (Estimate)

September 26, 2008

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1449

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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