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

February 16, 2012
April 11, 2012
September 2004
December 2006   (final data collection date for primary outcome measure)
Change in HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01536600 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Observational Study of Biphasic Insulin Aspart 30 Alone or in Combination With Oral Hypoglycaemic Agents in Subjects With Type 2 Diabetes
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with type 2 diabetes who were not adequately controlled on their current therapy and who were prescribed biphasic insulin aspart 30 (NovoMix® 30)

  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
The insulin dose and regimen was individualised at the physician's discretion
BIAsp 30 users
Intervention: Drug: biphasic insulin aspart 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33010
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
China,   India,   Iraq,   Jordan,   Korea, Republic of,   Lebanon,   Russian Federation,   Saudi Arabia,   South Africa,   Sri Lanka,   Turkey
 
NCT01536600
BIASP-1880
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Corporate Vice President for diabetes and devices Novo Nordisk A/S
Novo Nordisk A/S
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP