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Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes (PreFER)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00605020
First received: January 17, 2008
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in Europe.

The aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: insulin detemir
Drug: insulin aspart
Device: biphasic 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: Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 6 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: Yes ]
  • Adverse events [ Designated as safety issue: Yes ]
  • Difference of HbA1c change between the two groups [ Time Frame: after 13 weeks of treatment ] [ Designated as safety issue: No ]
  • Fasting plasma glucose of treatment [ Time Frame: after 13 and 26 weeks ] [ Designated as safety issue: No ]
  • Change in weight [ Designated as safety issue: No ]

Enrollment: 719
Study Start Date: December 2003
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: insulin detemir
    Other Name: Levemir
    Drug: insulin aspart Device: biphasic insulin aspart
  Eligibility

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

Inclusion Criteria:

  • Type 2 diabetes
  • Duration of type 2 diabetes for at least 6 months since diagnosis
  • Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
  • BMI below 40 kg/m2
  • HbA1c between 7-12%
  • Able and willing to perform self-monitoring of capillary blood glucose

Exclusion Criteria:

  • Current antidiabetic treatment with combination of three or more oral antidiabetic drugs
  • Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
  • Known or suspected allergy to trial product or related products
  • Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
  • Receipt of any investigational drug within 4 weeks prior to this trial
  • Previous participation in this trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605020

Locations
Austria
Wien, Austria, A 1090
Germany
Tübingen, Germany, 72072
Switzerland
Lugano, Switzerland, 6900
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Jens Larsen Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00605020     History of Changes
Other Study ID Numbers: NN304-1558
Study First Received: January 17, 2008
Last Updated: June 19, 2012
Health Authority: Austria: Federal Ministry for Health and Women
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on May 16, 2013