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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:
ClinicalTrials.gov Identifier:
NCT01536600
First Posted: February 22, 2012
Last Update Posted: January 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
February 16, 2012
February 22, 2012
January 6, 2017
September 2004
December 2006   (Final data collection date for primary outcome measure)
Change in HbA1c (glycosylated haemoglobin)
Same as current
Complete list of historical versions of study NCT01536600 on ClinicalTrials.gov Archive Site
  • Change in post prandial glucose (PPG)
  • Change in fasting glucose (FG)
  • Difference in prandial glucose increment (PGI)
  • Incidence of hypoglycaemic episodes
  • Adverse drug reactions (ADR)
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

*   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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
China,   India,   Iraq,   Jordan,   Lebanon,   Russian Federation,   Saudi Arabia,   South Africa,   Sri Lanka,   Turkey
 
NCT01536600
BIASP-1880
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017