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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01487421
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : June 24, 2014
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: insulin aspart Drug: insulin detemir

Study Type : Observational
Actual Enrollment : 2134 participants
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
Study Start Date : July 2003
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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)

Primary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures :
  1. Fasting blood glucose (FBG)
  2. 2-hours postprandial blood glucose
  3. Hypoglycemia
  4. Weight development
  5. Adverse Drug Reactions (ADRs) including Serious Adverse Drug Reactions (SADRs)

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Inclusion Criteria:

  • Type 2 diabetes
  • OAD monotherapy
  • OAD combination therapy
  • Therapy with OAD and basal insulin
  • Conventional insulin therapy with premixed insulin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01487421

Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01487421     History of Changes
Other Study ID Numbers: ANA-1934
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs