Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy (INITIATE)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00598793
First received: January 11, 2008
Last updated: June 5, 2012
Last verified: June 2012

January 11, 2008
June 5, 2012
November 2002
March 2004   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 28 weeks of treatment ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: after 28 weeks of treatment ]
Complete list of historical versions of study NCT00598793 on ClinicalTrials.gov Archive Site
  • Postprandial glucose by 8-point SMBG [ Designated as safety issue: No ]
  • Number of subjects achieving HbA1c below 7% [ Designated as safety issue: No ]
  • Number of hypoglycemic episodes and adverse events [ Designated as safety issue: No ]
  • Weight change [ Designated as safety issue: No ]
  • Insulin dose [ Designated as safety issue: No ]
  • Postprandial glucose by 8-point SMBG
  • Number of subjects achieving HbA1c below 7%
  • Number of hypoglycemic episodes and adverse events
  • Weight change
  • Insulin dose
Not Provided
Not Provided
 
Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy
Biphasic Insulin Aspart 70/30 + Metformin Compared to Insulin Glargine + Metformin in Type 2 Diabetes Failing OAD Therapy

This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.

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: insulin glargine
  • Drug: metformin
  • Drug: pioglitazone
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
242
March 2004
March 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Insulin naive Type 2 diabetes
  • Currently treated with OADs alone or combined with other treatment for at least 3 months
  • BMI below 40 kg/m2 and body weight below 125 kg
  • HbA1c greater than or equal to 8%

Exclusion Criteria:

  • Inability to tolerate metformin or contradictions to its use
  • Pregnant, breastfeeding or intention of becoming pregnant
  • Allergy to any of the trial products
  • Inability or unwillingness to perform SMBG
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00598793
BIASP-2163
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Plamen Kozlovski Novo Nordisk A/S
Novo Nordisk A/S
June 2012

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