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Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00595374
First received: January 7, 2008
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in Europe.

The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: insulin detemir
Drug: insulin NPH
Drug: insulin aspart
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart to Insulin NPH Plus Insulin Aspart in Adults With Type 1 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma glucose profiles [ Designated as safety issue: No ]
  • Change in body weight [ Designated as safety issue: No ]
  • Quality of Life [ Designated as safety issue: No ]
  • Incidence of adverse events [ Designated as safety issue: Yes ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: Yes ]

Enrollment: 114
Study Start Date: December 2003
Study Completion Date: October 2004
Primary Completion Date: October 2004 (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:

  • Duration of type 1 diabetes for at least 12 months
  • BMI below 35 kg/m2
  • HbA1c between 7.0-12.0%
  • Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
  • Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products
  • Previous participation in this trial
  • Receipt of any investigational products within the last 2 months prior to this trial
  • Drug or alcohol dependence
  • Pregnancy, breast-feeding or intention of becoming pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595374

Locations
Netherlands
Zwolle, Netherlands, 8025 AB
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Helene Philippo, MSc Novo Nordisk B.V.
  More Information

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00595374     History of Changes
Other Study ID Numbers: NN304-1582
Study First Received: January 7, 2008
Last Updated: June 19, 2012
Health Authority: Netherlands: Dutch Health Care Inspectorate

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

ClinicalTrials.gov processed this record on May 16, 2013