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Safety of Treatment Initiation With Biphasic Insulin Aspart 30 in Hospitalised Patients With Type 2 Diabetes

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.
 
ClinicalTrials.gov Identifier: NCT01565733
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Europe. The aim of this study is to evaluate the safety and efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2 diabetes with the aim of intensifying their treatment.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30

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Study Type : Observational
Actual Enrollment : 2223 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter, Open Label, Non-randomized, Non-interventional Observational Study of Safety of Treatment Initiation With a Biphasic Insulin Aspart (NovoMix® 30) in Hospitalized Patients With Type 2 Diabetes Mellitus
Study Start Date : January 2007
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
NovoMix® 30 users Drug: biphasic insulin aspart 30
Biphasic insulin aspart 30 prescribed solely on the basis of clinical judgement. Initial dose, frequency of injections and further dosage amendments at the discretion of the treating physician.




Primary Outcome Measures :
  1. Frequency of severe hypoglycaemic episodes

Secondary Outcome Measures :
  1. Number of severe hypoglycaemic episodes
  2. Number of mild hypoglycaemic episodes
  3. Postprandial glucose concentration after breakfast, lunch, and dinner
  4. Average fasting glucose concentration after waking and before main meals
  5. Average plasma glucose level at bedtime and at night


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with type 2 diabetes requiring treatment with NovoMix® 30 insulin on admission who before hospitalisation had been treated with oral antidiabetics and/or human insulin
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes
  • Treated with oral anti-diabetics and/or human insulin

Exclusion Criteria:

  • Persons previously included in the trial
  • Hypersensitive to biphasic insulin aspart or any of the excipients
  • Pregnant or lactating women, or those who plan to get pregnant within the next 12 months

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 ClinicalTrials.gov identifier (NCT number): NCT01565733


Locations
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Poland
Novo Nordisk Investigational Site
Warszawa, Poland, PL-02-274
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01565733     History of Changes
Other Study ID Numbers: BIASP-4017
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Isophane
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs