Official Title: “Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin Naive Subjects With Type 2 Diabetes.”

This trial is conducted in Africa, Asia, Europe, Oceania and South America.

This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: biphasic insulin aspart
  • Treat-to-target dose titration scheme
• Drug: insulin glargine
  • Treat-to-target dose titration scheme
• Drug: metformin
  • Tablets, 2550 mcg. Administered once daily
• Drug: glimepiride
  • tablets 2 mg. 4, 6 or 8 mg administered once daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Active Comparator: B

Primary Measures

• HbA1c
  • Time Frame: After 26 weeks of treatment
    Safety Issue?: No

Secondary Measures

• 9-point plasma glucose profiles
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: No
• Percentage of subjects reaching certain levels of HbA1c
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: No
• Number of hypoglycaemic episodes
  • Time Frame: during the trial
    Safety Issue?: Yes
• Treatment Satisfaction
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: No
• Adverse events (AEs)
  • Time Frame: during the trial
    Safety Issue?: Yes

Inclusion Criteria:

• Type 2 diabetes
• Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
• Ongoing stable treatment with metformin for at least 2 months
• Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
• Insulin naive
• HbA1c between 7.0% and 11.0% (inclusive of both values)

Exclusion Criteria:

• Metformin contraindication according to local practice
• TZD treatment for the last 5 months before trial start
• Systemic treatment with any corticosteroid 3 months before trial start
• Any disease or condition which according to the Investigator would interfere with the trial

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novo Nordisk

Overall Clinical Trial Officials and Contacts

Pernille Gad, MSc Study Director Novo Nordisk A/S  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00469092

Study ID Number: BIASP-1731

ClinicalTrials.gov Identifier: NCT00469092

Health Authority: France: Afssaps - French Health Products Safety Agency

Clinical Trials at Novo Nordisk