This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00104182
First received: February 23, 2005
Last updated: January 27, 2017
Last verified: January 2017
  Purpose
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir Drug: insulin NPH 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 Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients With 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 20 weeks ]

Secondary Outcome Measures:
  • Adverse events
  • body weight
  • Hypoglycemia
  • Blood glucose

Enrollment: 503
Study Start Date: February 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (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
  • Currently treated with Oral Antidiabetic Drugs
  • BMI lesser than or equal to 40 kg/m2
  • HbA1c greater than or equal 7.5 and lesser than or equal to 11%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial
  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: NCT00104182

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35235
United States, Arizona
Novo Nordisk Investigational Site
Mesa, Arizona, United States, 85205
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85029
United States, California
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
Novo Nordisk Investigational Site
Concord, California, United States, 94520
Novo Nordisk Investigational Site
Fullerton, California, United States, 92835
Novo Nordisk Investigational Site
La Jolla, California, United States, 92037
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057
Novo Nordisk Investigational Site
Orange, California, United States, 92869
Novo Nordisk Investigational Site
Poway, California, United States, 92064
United States, Colorado
Novo Nordisk Investigational Site
Denver, Colorado, United States, 80220
United States, Florida
Novo Nordisk Investigational Site
Lake Mary, Florida, United States, 32746
United States, Illinois
Novo Nordisk Investigational Site
Springfield, Illinois, United States, 62711
United States, Massachusetts
Novo Nordisk Investigational Site
Fall River, Massachusetts, United States, 02721
Novo Nordisk Investigational Site
Waltham, Massachusetts, United States, 02453
United States, Missouri
Novo Nordisk Investigational Site
Jefferson City, Missouri, United States, 65109
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89030
United States, New York
Novo Nordisk Investigational Site
Lewiston, New York, United States, 14092
Novo Nordisk Investigational Site
Williamsville, New York, United States, 14221
United States, North Dakota
Novo Nordisk Investigational Site
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45291
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45406
United States, Pennsylvania
Novo Nordisk Investigational Site
Connellsville, Pennsylvania, United States, 15425
Novo Nordisk Investigational Site
Lancaster, Pennsylvania, United States, 17601
Novo Nordisk Investigational Site
Norristown, Pennsylvania, United States, 19401
United States, South Carolina
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
United States, Texas
Novo Nordisk Investigational Site
Conroe, Texas, United States, 77384
Novo Nordisk Investigational Site
Killeen, Texas, United States, 76543
United States, Washington
Novo Nordisk Investigational Site
Seattle, Washington, United States, 98105
Denmark
Novo Nordisk Investigational Site
Aalborg, Denmark, 9000
Novo Nordisk Investigational Site
Esbjerg, Denmark, 6700
Novo Nordisk Investigational Site
Glostrup, Denmark, 2600
Novo Nordisk Investigational Site
Herlev, Denmark, 2730
Novo Nordisk Investigational Site
Hillerød, Denmark, 3400
Novo Nordisk Investigational Site
Hjørring, Denmark, 9800
Novo Nordisk Investigational Site
Horsens, Denmark, 8700
Novo Nordisk Investigational Site
Hvidovre, Denmark, 2650
Novo Nordisk Investigational Site
København S, Denmark, 2300
Novo Nordisk Investigational Site
København, Denmark, 2400
Novo Nordisk Investigational Site
Næstved, Denmark, 4700
Novo Nordisk Investigational Site
Roskilde, Denmark, 4000
France
Novo Nordisk Investigational Site
Bagnols-sur-ceze, France, 30200
Novo Nordisk Investigational Site
Besancon, France, 25030
Novo Nordisk Investigational Site
Carcassonne, France, 11000
Novo Nordisk Investigational Site
Corbeil Essonnes, France, 91106
Novo Nordisk Investigational Site
DAX, France, 40107
Novo Nordisk Investigational Site
MONTPELLIER cedex 5, France, 34295
Novo Nordisk Investigational Site
Quimper, France, 29107
Novo Nordisk Investigational Site
Rueil-malmaison, France, 92501
Novo Nordisk Investigational Site
Tours, France, 37044
Novo Nordisk Investigational Site
Venissieux, France, 69200
Italy
Novo Nordisk Investigational Site
Cagliari, Italy, 09134
Novo Nordisk Investigational Site
Catania, Italy, 95126
Novo Nordisk Investigational Site
Genova, Italy, 16132
Novo Nordisk Investigational Site
Messina, Italy, 98123
Novo Nordisk Investigational Site
Monza, Italy, 20052
Novo Nordisk Investigational Site
Napoli, Italy, 80131
Novo Nordisk Investigational Site
Parma, Italy, 43100
Novo Nordisk Investigational Site
Pescara, Italy, 65124
Novo Nordisk Investigational Site
Prato, Italy, 59100
Novo Nordisk Investigational Site
Roma, Italy, 00161
Novo Nordisk Investigational Site
Torino, Italy, 10126
Novo Nordisk Investigational Site
Treviso, Italy, 31100
Netherlands
Novo Nordisk Investigational Site
Almelo, Netherlands, 7609 PP
Novo Nordisk Investigational Site
Den Bosch, Netherlands, 5216 GC
Novo Nordisk Investigational Site
Den Haag, Netherlands, 2584 HV
Novo Nordisk Investigational Site
Etten-Leur, Netherlands, 4872 LP
Novo Nordisk Investigational Site
Roelofarendsveen, Netherlands, 2371 RB
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3082 DC
Novo Nordisk Investigational Site
Vlodrop, Netherlands, 6063 DA
Norway
Novo Nordisk Investigational Site
Bergen, Norway, 5021
Novo Nordisk Investigational Site
Bergen, Norway, NO-5012
Novo Nordisk Investigational Site
Elverum, Norway, 2408
Novo Nordisk Investigational Site
Gjøvik, Norway, NO-2819
Novo Nordisk Investigational Site
Kongsvinger, Norway, 2212
Novo Nordisk Investigational Site
Oslo, Norway, 0370
Novo Nordisk Investigational Site
Oslo, Norway, 0586
Novo Nordisk Investigational Site
Stavanger, Norway, 4011
Novo Nordisk Investigational Site
Trondheim, Norway, NO-7030
Spain
Novo Nordisk Investigational Site
Alcorcón, Spain, 28922
Novo Nordisk Investigational Site
Almería, Spain, 04009
Novo Nordisk Investigational Site
Barcelona, Spain, 08017
Novo Nordisk Investigational Site
Barcelona, Spain, 08025
Novo Nordisk Investigational Site
Barcelona, Spain, 08035
Novo Nordisk Investigational Site
Bilbao, Spain, 48013
Novo Nordisk Investigational Site
Cádiz, Spain, 11009
Novo Nordisk Investigational Site
Getafe, Spain, 28905
Novo Nordisk Investigational Site
Gijón, Spain, 33206
Novo Nordisk Investigational Site
Granada, Spain, 18012
Novo Nordisk Investigational Site
Palma de Mallorca, Spain, 07198
Novo Nordisk Investigational Site
Pamplona, Spain, 31008
Novo Nordisk Investigational Site
Santa Cruz de Tenerife, Spain, 38010
Novo Nordisk Investigational Site
Santiago de Compostela, Spain, 15706
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Novo Nordisk Investigational Site
Valladolid, Spain, 47010
Novo Nordisk Investigational Site
Valladolid, Spain, 47011
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: NCT00104182     History of Changes
Other Study ID Numbers: NN304-1632
2004-001461-18 ( EudraCT Number )
Study First Received: February 23, 2005
Last Updated: January 27, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Detemir
Insulin, Isophane
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017