Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

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.

Intervention(s) in this Clinical Trial

• Drug: biphasic insulin aspart
  • Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
• Drug: insulin glargine
  • Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
• 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

• Experimental: BIAsp 30
  • biphasic insulin aspart 30 + metformin + glimepiride
• Active Comparator: Glargine
  • insulin glargine + metformin + glimepiride

Primary Measures

• Glycosylated Haemoglobin A1c (HbA1c)
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: No

Secondary Measures

• 9-point Self-measured Plasma Glucose Profiles
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: No
• Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: No
• Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: No
• Number of Hypoglycaemic Episodes
  • Time Frame: weeks 0-26
    Safety Issue?: Yes
• Number of Subjects Reporting Treatment Emergent Adverse Events
  • Time Frame: weeks 0-26
    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 (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)

Exclusion Criteria:

• Metformin contraindication according to local practice
• TZD (thiazolidinedione) 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 Investigator: Novo Nordisk Industry

Overall Clinical Trial Officials and Contacts

Pernille Gad, MSc Study Director Novo Nordisk  

Information obtained from ClinicalTrials.gov on February 09, 2012

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