Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 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. Identifier: NCT00274274
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : November 21, 2014
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir Drug: insulin aspart Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 373 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Insulin Aspart in a Fixed or Flexible Supplementary Insulin Therapy Regimen, With or Without Insulin Detemir in Type 2 Diabetes
Study Start Date : September 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 52 weeks ]

Secondary Outcome Measures :
  1. Blood glucose profiles
  2. Percentage of patients with HbA1c less than 7.0% after 52 weeks
  3. Quality of Life
  4. Frequency of BG measurements
  5. Safety parameters
  6. Duration of education

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

Inclusion Criteria:

  • Type 2 Diabetes for more than 6 months
  • Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months
  • Body Mass Index (BMI) less than or equal to 40 kg/m2
  • HbA1c 7.0-11.0%

Exclusion Criteria:

  • Treatment with short acting insulin(s) for longer than 10 days
  • Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization
  • Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months

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 identifier (NCT number): NCT00274274

Düsseldorf, Germany
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00274274     History of Changes
Other Study ID Numbers: NN304-1657
2005-000319-87 ( EudraCT Number )
First Posted: January 10, 2006    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014

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