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Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT00184665
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin detemir Drug: insulin NPH Drug: insulin aspart Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.
Study Start Date : June 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources




Primary Outcome Measures :
  1. HbA1c [ Time Frame: after a two-year trial period ]

Secondary Outcome Measures :
  1. Adverse events
  2. Body weight
  3. Antibodies
  4. Body composition
  5. Blood glucose
  6. Hypoglycaemia


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes
  • Currently on basal-bolus regimen
  • BMI = 35.0 kg/m2
  • HbA1c =11.0%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Cardial problems
  • Uncontrolled hypertension
  • Impaired hepatic or renal function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184665


  Show 29 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184665     History of Changes
Other Study ID Numbers: NN304-1595
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Aspart
Insulin Detemir
Insulin, Isophane
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs