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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01542060
First received: February 15, 2012
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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 Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Secondary Outcome Measures:
  • FBG (Fasting Blood Glucose) [ Designated as safety issue: No ]
  • Quality of life assessed through the WHO-DTSQ (World Health Organization-Diabetes Treatment Satisfaction Questionnaire) [ Designated as safety issue: No ]
  • Incidence of adverse events [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]

Enrollment: 298
Study Start Date: January 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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

Patients from hospitals or clinics diagnosed with type 2 diabetes mellitus

Criteria

Inclusion Criteria:

  • Subjects from hospitals or clinics, diagnosed with type 2 diabetes mellitus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542060

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

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01542060     History of Changes
Other Study ID Numbers: BIASP-1892
Study First Received: February 15, 2012
Last Updated: April 11, 2012
Health Authority: Jordan: Ministry of Health

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

ClinicalTrials.gov processed this record on July 23, 2014