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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00760448
First received: September 25, 2008
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: insulin detemir
Drug: insulin NPH
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Trial Investigating the Hypoglycaemic Response to Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: April 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760448

Locations
United Kingdom
Guildford, United Kingdom, GU2 7XX
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Hanne Haahr, PhD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00760448     History of Changes
Other Study ID Numbers: NN304-1449
Study First Received: September 25, 2008
Last Updated: June 19, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin
Insulin, NPH
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013