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Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00097084
First received: November 17, 2004
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type 2 diabetes.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: insulin glargine
Drug: insulin aspart
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 1 year trial period ]

Secondary Outcome Measures:
  • Adverse events
  • Body weight
  • Hypoglycemia
  • Blood glucose
  • Insulin Treatment Satisfaction

Enrollment: 324
Study Start Date: September 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Type 2 diabetes for at least 12 months
  • Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs
  • BMI of maximum 40 kg/m2
  • HbA1c greater than or equal to 7.0% and less than or equal to 11.0%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Impaired hepatic or renal function
  • Cardiac problems or uncontrolled hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097084

  Hide Study Locations
Locations
United States, Arkansas
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72204
United States, California
Novo Nordisk Investigational Site
Inglewood, California, United States, 90301
Novo Nordisk Investigational Site
San Francisco, California, United States, 94143-0780
Novo Nordisk Investigational Site
Santa Ana, California, United States, 92705
Novo Nordisk Investigational Site
Spring Valley, California, United States, 91978
United States, Florida
Novo Nordisk Investigational Site
Boca Raton, Florida, United States, 33433
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32216
Novo Nordisk Investigational Site
Lake Mary, Florida, United States, 32746
Novo Nordisk Investigational Site
Melbourne, Florida, United States, 32901
Novo Nordisk Investigational Site
Orlando, Florida, United States, 32804
Novo Nordisk Investigational Site
Palm Harbor, Florida, United States, 34684
Novo Nordisk Investigational Site
Vero Beach, Florida, United States, 32960
United States, Georgia
Novo Nordisk Investigational Site
Athens, Georgia, United States, 30606
United States, Idaho
Novo Nordisk Investigational Site
Idaho Falls, Idaho, United States, 83404-7596
United States, Kansas
Novo Nordisk Investigational Site
Topeka, Kansas, United States, 66606
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68114
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89119-6100
United States, New Jersey
Novo Nordisk Investigational Site
Berlin, New Jersey, United States, 08009
United States, North Carolina
Novo Nordisk Investigational Site
Asheville, North Carolina, United States, 28803
United States, Pennsylvania
Novo Nordisk Investigational Site
Hermitage, Pennsylvania, United States, 16148
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75235
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-8858
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Novo Nordisk Investigational Site
Newport News, Virginia, United States, 23606
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23249
United States, Washington
Novo Nordisk Investigational Site
Tacoma, Washington, United States, 98405
Finland
Novo Nordisk Investigational Site
Espoo, Finland, 02740
Novo Nordisk Investigational Site
Helsinki, Finland, 00260
Novo Nordisk Investigational Site
Kurikka, Finland, FI-61300
Novo Nordisk Investigational Site
Lahti, Finland, FI-15110
Novo Nordisk Investigational Site
Lapua, Finland, FI-62100
Novo Nordisk Investigational Site
Oulu, Finland, FI-90220
Novo Nordisk Investigational Site
Turku, Finland, 20700
France
Novo Nordisk Investigational Site
Brest, France, 29200
Novo Nordisk Investigational Site
Le Mans, France
Novo Nordisk Investigational Site
MONTPELLIER cedex 5, France, 34295
Novo Nordisk Investigational Site
Nanterre, France, 92014
Novo Nordisk Investigational Site
Narbonne, France, 11108
Novo Nordisk Investigational Site
NEVERS cedex, France, 58033
Novo Nordisk Investigational Site
Orleans, France
Novo Nordisk Investigational Site
Paris, France, 75181
Novo Nordisk Investigational Site
Venissieux, France, 69200
Norway
Novo Nordisk Investigational Site
Bergen, Norway, NO-5009
Novo Nordisk Investigational Site
Notodden, Norway, NO-3675
Novo Nordisk Investigational Site
Sarpsborg, Norway, 1723
Novo Nordisk Investigational Site
Ski, Norway, NO-1400
Novo Nordisk Investigational Site
Stavanger, Norway, 4011
Novo Nordisk Investigational Site
Trondheim, Norway, NO-7030
Sweden
Novo Nordisk Investigational Site
Falun, Sweden, 791 82
Novo Nordisk Investigational Site
Göteborg, Sweden, 417 17
Novo Nordisk Investigational Site
Kalmar, Sweden, 391 85
Novo Nordisk Investigational Site
Lund, Sweden, 221 85
Novo Nordisk Investigational Site
Lund, Sweden, 223 70
Novo Nordisk Investigational Site
Malmö, Sweden, 214 26
Novo Nordisk Investigational Site
Motala, Sweden, 591 85
Novo Nordisk Investigational Site
Oskarshamn, Sweden, 572 28
Novo Nordisk Investigational Site
Uddevalla, Sweden, 451 50
Novo Nordisk Investigational Site
Ängelholm, Sweden, 262 91
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00097084     History of Changes
Other Study ID Numbers: NN304-1431
2004-000087-27 ( EudraCT Number )
Study First Received: November 17, 2004
Last Updated: January 26, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017