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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01536600
First received: February 16, 2012
Last updated: April 11, 2012
Last verified: April 2012
  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

Genders Eligible for Study:   Both
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
China, Beijing
Beijing, Beijing, China, 100004
India
Bangalore, India, 560001
Iraq
Amman, Iraq, 11844
Jordan
Amman, Jordan, 11844
Korea, Republic of
Seoul, Korea, Republic of, 137-920
Lebanon
Amman, Lebanon, 11844
Russian Federation
Moscow, Russian Federation, 119330
Saudi Arabia
Riyadh, Saudi Arabia, 3542
South Africa
Sandton, South Africa, 2146
Sri Lanka
Bangalore, Sri Lanka, 560001
Turkey
Istanbul, Turkey, 34335
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: NCT01536600     History of Changes
Other Study ID Numbers: BIASP-1880
Study First Received: February 16, 2012
Last Updated: April 11, 2012
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 aspart
Insulin
Hypoglycemic Agents
Insulin, NPH
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014