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Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00592969
First received: January 2, 2008
Last updated: October 18, 2013
Last verified: October 2013

January 2, 2008
October 18, 2013
December 2003
November 2004   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: after 12 weeks of treatment ]
Complete list of historical versions of study NCT00592969 on ClinicalTrials.gov Archive Site
  • PPBG values [ Designated as safety issue: No ]
  • Glucose profiles [ Designated as safety issue: No ]
  • Hypoglycemia [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
  • PPBG values
  • Glucose profiles
  • Hypoglycemia
  • Adverse events
Not Provided
Not Provided
 
Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes
Evaluation of Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart or Insulin NPH in Subjects With Type 2 Diabetes

This trial is conducted in South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects with type 2 diabetes.

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: metformin
  • 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
164
November 2004
November 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • Currently treated with insulin NPH or are insulin-naive
  • Body mass index (BMI) below 35.0 kg/m2
  • HbA1c between 7.5-11.0%

Exclusion Criteria:

  • Participation in any other clinical trial involving investigational products within the last 3 months
  • History of drug or alcohol dependence
  • Known impaired hepatic function
  • Known or suspected allergy to human insulin NPH, insulin aspart or any component of the composition
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil
 
NCT00592969
BIASP-1570
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Plamen Kozlovski Novo Nordisk A/S
Novo Nordisk A/S
October 2013

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