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An Observational Study of Insulin Aspart and, if Necessary, Insulin Levemir (FlexPen®) in the Evening or at Bedtime

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01487421
First received: November 25, 2011
Last updated: December 5, 2011
Last verified: December 2011
History of Changes
  Purpose

This study is conducted in Europe. The aim of this study is investigate the potential of a supplementary insulin therapy regimen (SIT) as intensification for insufficiently controlled patients with type 2 diabetes in a normal diabetes care setting.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
 Drug: insulin aspart
Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Physiological Therapy of Type 2 Diabetes - NovoRapid® FlexPen® Before Meals, Additionally Levemir® FlexPen® in the Evening or at Bedtime if Needed

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting blood glucose (FBG) [ Designated as safety issue: No ]
  • 2-hours postprandial blood glucose [ Designated as safety issue: No ]
  • Hypoglycemia [ Designated as safety issue: No ]
  • Weight development [ Designated as safety issue: No ]
  • Adverse Drug Reactions (ADRs) including Serious Adverse Drug Reactions (SADRs) [ Designated as safety issue: No ]

Enrollment: 2134
Study Start Date: July 2003
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SIT Drug: insulin aspart
Subjects were observed over a time period of 12 weeks after initiation of a supplementary insulin therapy regimen (SIT) with insulin aspart at mealtimes. Administrated subcutaneously (s.c., under the skin)
Drug: insulin detemir
Insulin detemir were added to insulin aspart in the evening or at bedtime, if needed. Administrated subcutaneously (s.c., under the skin)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with insufficiently controlled type 2 diabetes mellitus treated with diet, OAD (oral anti-diabetes drug), long acting insulin, premixed insulin or a combination

Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • OAD monotherapy
  • OAD combination therapy
  • Therapy with OAD and basal insulin
  • Conventional insulin therapy with premixed insulin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487421

Locations
Germany
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: H. Andersen 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: NCT01487421     History of Changes
Other Study ID Numbers: ANA-1934
Study First Received: November 25, 2011
Last Updated: December 5, 2011
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 May 19, 2013