Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes (EUROMIX)

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00619697

BIASP-1564

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes for at least 6 months
• Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed
• Previous treatment with oral antidiabetic drugs for at least 4 months
• Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
• BMI below 40 kg/m2
• HbA1c between 7-12%
• Able and willing to perform self-plasma glucose monitoring

Exclusion criteria

• The receipt of any other investigational drug within 4 weeks before screening
• A history of drug or alcohol abuse within the last 12 months
• Severe, uncontrolled hypertension
• Known or suspected allergy to trial products or related products

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)