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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00274274
First received: January 9, 2006
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274274

Locations
Germany
Düsseldorf, Germany
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Til Rendschmidt Novo Nordisk Pharma GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00274274     History of Changes
Other Study ID Numbers: NN304-1657, 2005-000319-87
Study First Received: January 9, 2006
Last Updated: June 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014