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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00097084
First received: November 17, 2004
Last updated: June 19, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Designated as safety issue: Yes ]
  • Body weight [ Designated as safety issue: No ]
  • Hypoglycemia [ Designated as safety issue: Yes ]
  • Blood glucose [ Designated as safety issue: No ]
  • Insulin Treatment Satisfaction [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097084

  Show 30 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Per Clauson, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00097084     History of Changes
Other Study ID Numbers: NN304-1431, 2004-000087-27
Study First Received: November 17, 2004
Last Updated: June 19, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Finland: Finnish Medicines Agency
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014