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

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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