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Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00280046
First received: January 19, 2006
Last updated: June 15, 2012
Last verified: June 2012

January 19, 2006
June 15, 2012
November 2003
July 2004   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]
- HbA1c, measured after 16 weeks of treatment
Complete list of historical versions of study NCT00280046 on ClinicalTrials.gov Archive Site
  • Self-measured 7-point capillary plasma glucose profile [ Designated as safety issue: No ]
  • Change in body weight [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes and adverse events [ Designated as safety issue: No ]
  • Quality of Life [ Designated as safety issue: No ]
  • - Self-measured 7-point capillary plasma glucose profile
  • - Change in body weight
  • - Incidence of hypoglycaemic episodes and adverse events
  • - Quality of Life
Not Provided
Not Provided
 
Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes
Effect of Biphasic Insulin Aspart 30 on Glycaemic Control in Subjects With Type 2 Diabetes

This trial was conducted in Russian Federation. This trial aimed for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different treatment regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in combination with metformin and treatment with oral anti-diabetic drugs.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
307
July 2004
July 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes, currently treated with one or more oral hypoglycemic agent
  • HbA1c: At least 8.0%

Exclusion Criteria:

  • Impaired hepatic, renal or cardiac function
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00280046
BIASP-1554
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Ninella Starkova, MD, PhD Novo Nordisk Russia
Novo Nordisk A/S
June 2012

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