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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart; Drug: metformin; Drug: glimepiride; Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00469092

2006-003288-29 (EudraCT Number)

BIASP-1731

Details and patient eligibility

About

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.

Enrollment: 480 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

BIAsp 30

Experimental group

Treatment:

Drug: metformin

Drug: glimepiride

Drug: biphasic insulin aspart

Glargine

Active Comparator group

Treatment:

Drug: metformin

Drug: insulin glargine

Drug: glimepiride