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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00624364
First received: February 15, 2008
Last updated: June 18, 2012
Last verified: June 2012
History of Changes

February 15, 2008
June 18, 2012
May 2004
May 2005   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00624364 on ClinicalTrials.gov Archive Site
  • Plasma glucose profiles [ Designated as safety issue: No ]
  • Cardiovascular risk factors [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
  • Plasma glucose profiles [ Designated as safety issue: No ]
  • Cardiovascular risk factors [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Biphasic Insulin Aspart 30 With Metformin in Type 2 Diabetes
Comparison of Efficacy and Safety of Biphasic Insulin Aspart Plus Metformin to Biphasic Insulin Aspart Monotherapy in Subjects With Type 2 Diabetes

This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood glucose control in 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: biphasic insulin aspart
  • Drug: metformin
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
140
May 2005
May 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • Currently treated with maximum doses of any kind of OAD alone or any kind of oral combination therapy for at least 2 months
  • Body mass index (BMI) below 40.0 kg/m2
  • HbA1c between 7.5-13.0%

Exclusion Criteria:

  • History of drug or alcohol dependence
  • Mental incapacity, unwillingness or language barriers precluding adequate
  • Subjects previously screened to participation or having already participated in this trial
  • Receipt of any investigational drug within the last month prior to this trial
  • Known or suspected allergy to trial products or related products
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00624364
BIASP-1579
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Timothy Kedijang, MBChB, MSc Novo Nordisk Pty. Ltd.
Novo Nordisk
June 2012

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