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Observational Study of Biphasic Insulin Aspart 30 Alone or in Combination With Oral Hypoglycaemic Agents in Subjects With Type 2 Diabetes (PRESENT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01536600
First received: February 16, 2012
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice.

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 Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix 30 as Monotherapy, or in Combination With OHAs, in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Change in post prandial glucose (PPG) [ Designated as safety issue: No ]
  • Change in fasting glucose (FG) [ Designated as safety issue: No ]
  • Difference in prandial glucose increment (PGI) [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Adverse drug reactions (ADR) [ Designated as safety issue: No ]

Enrollment: 33010
Study Start Date: September 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BIAsp 30 users Drug: biphasic insulin aspart 30
The insulin dose and regimen was individualised at the physician's discretion

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with type 2 diabetes who were not adequately controlled on their current therapy and who were prescribed biphasic insulin aspart 30 (NovoMix® 30)
Criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy
  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: NCT01536600

Locations
Korea, Republic of
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 137-920
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01536600     History of Changes
Other Study ID Numbers: BIASP-1880 
Study First Received: February 16, 2012
Last Updated: January 5, 2017
Health Authority: China: Ministry of Health
India: Ministry of Health and Family Wellfare
Iraq: Ministry of Health
Lebanon: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
Saudi Arabia: Ministry of Health
South Africa: Medicines Control Council
South Korea: Institutional Review Board
Sri Lanka: Ministry of Health
Turkey: Ministry of Health Drug and Pharmaceutical Department
Jordan: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin degludec, insulin aspart drug combination
Insulin
Insulin, Isophane
Biphasic Insulins
Insulin Aspart
Hypoglycemic Agents
Insulin, Long-Acting
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on January 17, 2017