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Observational Study on Efficacy, Safety and Convenience of Using Mixtard® 30 NovoLet® Alone or Combined With OHA in Treatment of Type 2 Diabetes in Routine Clinical Practice

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01492166
First received: December 12, 2011
Last updated: April 11, 2012
Last verified: April 2012
History of Changes

December 12, 2011
April 11, 2012
November 2006
June 2007   (final data collection date for primary outcome measure)
  • Change in fasting blood glucose (FBG) [ Designated as safety issue: No ]
  • Change in 2-hour post prandial blood glucose [ Designated as safety issue: No ]
  • Change in HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
  • Change in prandial glucose increment (PGI) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01492166 on ClinicalTrials.gov Archive Site
  • Frequency of minor and major hypoglycaemia [ Designated as safety issue: No ]
  • Occurrence of Adverse Drug Reactions (ADR) [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study on Efficacy, Safety and Convenience of Using Mixtard® 30 NovoLet® Alone or Combined With OHA in Treatment of Type 2 Diabetes in Routine Clinical Practice
A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Mixtard® 30 NovoLet® as Monotherapy, or in Combination With Oral Hypoglycaemic Agent ( OHA ), in Treatment of Subjects With Type 2 Diabetes in Routine Clinical Practice

This study is conducted in Asia. The aim of this study is to assess the efficacy, safety and convenience of the use of Mixtard® 30 NovoLet® used alone or combined with oral hypoglycaemic agent (OHA) in the management of type 2 diabetes mellitus in an out-patient setting.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Subjects with type 2 diabetes not achieving adequate control and being prescribed Mixtard® 30 Novolet® either as a single treatment or in combination with oral hypoglycaemic agents (OHAs).
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: biphasic human insulin 30
Dose and timing of dose for each subject was at the discretion of the attending physicians based on current clinical practice guidelines
Novolet®
Intervention: Drug: biphasic human insulin 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1935
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • Not adequately controlled on their current therapy
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01492166
NOPEN3-1890
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Corporate Vice President for diabetes and devices Novo Nordisk
Novo Nordisk
April 2012

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