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Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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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




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, Older Adult)
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


Locations
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Argentina
Novo Nordisk Investigational Site
Buenos Aires, Argentina
Novo Nordisk Investigational Site
Ciudad Autonoma de Bs As, Argentina, C1405CWB
Novo Nordisk Investigational Site
Ciudad Autónoma de BsAs, Argentina, C1406FWY
Novo Nordisk Investigational Site
Mar del Plata, Argentina, B7602CBM
Australia, New South Wales
Novo Nordisk Investigational Site
St Leonards, New South Wales, Australia, 2065
Australia, Tasmania
Novo Nordisk Investigational Site
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Novo Nordisk Investigational Site
Melbourne, Victoria, Australia, 3004
Australia
Novo Nordisk Investigational Site
Darlinghurst, Australia, 2010
Novo Nordisk Investigational Site
Melbourne, Australia, 3000
Novo Nordisk Investigational Site
Stones Corner, Australia, 4120
Novo Nordisk Investigational Site
Woodville, Australia, 5011
Bulgaria
Novo Nordisk Investigational Site
Plovdiv, Bulgaria, 4002
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1431
Croatia
Novo Nordisk Investigational Site
Zagreb, Croatia, 10 000
India
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, India, 632004
Novo Nordisk Investigational Site
Chennai, India, 600-013
Novo Nordisk Investigational Site
Hyderabad, India, 600034
Novo Nordisk Investigational Site
Mumbai, India, 400 0067
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Malaysia
Novo Nordisk Investigational Site
Cheras, Malaysia, 56000
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, Malaysia, 16150
Romania
Novo Nordisk Investigational Site
Bucharest, Romania, 020042
Novo Nordisk Investigational Site
Bucharest, Romania, 020475
South Africa
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2193
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 27 11
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 27 21
Novo Nordisk Investigational Site
Bloemfontein, South Africa, 27 51
Turkey
Novo Nordisk Investigational Site
Bornova-IZMIR, Turkey, 35100
Novo Nordisk Investigational Site
Istanbul, Turkey, 34390
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184665    
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:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs