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Efficacy and Safety of Biphasic Insulin Aspart 30 for the Treatment of Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01542060
Recruitment Status : Completed
First Posted : March 1, 2012
Last Update Posted : April 12, 2012
Information provided by:
Novo Nordisk A/S

Brief Summary:
This study is conducted in Asia. The aim of this observational study is to collect efficacy and safety data of biphasic insulin aspart (NovoMix® 30) in type 2 diabetes under normal clinical practice conditions.

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

Study Type : Observational
Actual Enrollment : 298 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Experience Programme to Collect Data on the Safety and Efficacy of NovoMix® 30 in the Treatment of Patients With Type 2 Diabetes in Jordan
Study Start Date : January 2004
Primary Completion Date : December 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
BIAsp 30 users Drug: biphasic insulin aspart 30
Administered via an insulin injection device. Dosages varied according to individual patients' medical requirement as determined by their attending clinician

Primary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures :
  1. FBG (Fasting Blood Glucose)
  2. Quality of life assessed through the WHO-DTSQ (World Health Organization-Diabetes Treatment Satisfaction Questionnaire)
  3. Incidence of adverse events
  4. Incidence of hypoglycaemic episodes

Information from the National Library of Medicine

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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 from hospitals or clinics diagnosed with type 2 diabetes mellitus

Inclusion Criteria:

  • Subjects from hospitals or clinics, diagnosed with type 2 diabetes mellitus

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): NCT01542060

Amman, Jordan, 11844
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Corporate Vice President for diabetes and devices Novo Nordisk A/S

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01542060     History of Changes
Other Study ID Numbers: BIASP-1892
First Posted: March 1, 2012    Key Record Dates
Last Update Posted: April 12, 2012
Last Verified: April 2012

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 aspart protamine drug combination 30:70
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs