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Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: January 9, 2006
Last updated: November 20, 2014
Last verified: November 2014

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: insulin aspart
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood glucose profiles [ Designated as safety issue: No ]
  • Percentage of patients with HbA1c less than 7.0% after 52 weeks [ Designated as safety issue: No ]
  • Quality of Life [ Designated as safety issue: No ]
  • Frequency of BG measurements [ Designated as safety issue: No ]
  • Safety parameters [ Designated as safety issue: No ]
  • Duration of education [ Designated as safety issue: No ]

Enrollment: 373
Study Start Date: September 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 identifier: NCT00274274

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

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S Identifier: NCT00274274     History of Changes
Other Study ID Numbers: NN304-1657, 2005-000319-87
Study First Received: January 9, 2006
Last Updated: November 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 25, 2014