Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetics Failing on OADs

• Status: Completed
• Trial end date: 2004-11-29
• 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 investigate the effectiveness of biphasic insulin aspart 30 in type 2 diabetics not achieving blood sugar levels when treated with oral anti-diabetics drugs (OADs) with or without basal insulin therapy.

• Phase: Phase 4
• 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, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Type 2 diabetes mellitus for at least 12 months

• HbA1c: 7.5-10.0%

• An antidiabetic regimen that has been stable for at least 3 months

• Able and willing to perform SMBG testing as per protocol

Exclusion Criteria:

• Use of any insulin preparations other than NPH or glargine within the past 6 months

• Pregnancy, breastfeeding, intention to become pregnant within the next 12 months, or judged to be using inadequate contraceptive measures (adequate contraceptive measures includes: sterilization, intrauterine devices, oral contraceptives, or consistent use of barrier methods)

• Known or suspected allergy to trial product or agents related to trial product