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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Glimepiride; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin degludec, insulin aspart drug combination; Insulin Glargine; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting; Metformin

Criteria

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