Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Insulin naive Type 2 diabetes

• Currently treated with OADs alone or combined with other treatment for at least 3 months

• BMI below 40 kg/m2 and body weight below 125 kg

• HbA1c greater than or equal to 8%

Exclusion Criteria:

• Inability to tolerate metformin or contradictions to its use

• Pregnant, breastfeeding or intention of becoming pregnant

• Allergy to any of the trial products

• Inability or unwillingness to perform SMBG