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

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

Summary

This trial is conducted in Europe.

The aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.

• 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 Detemir; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Type 2 diabetes

• Duration of type 2 diabetes for at least 6 months since diagnosis

• Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily

• BMI below 40 kg/m2

• HbA1c between 7-12%

• Able and willing to perform self-monitoring of capillary blood glucose

Exclusion Criteria:

• Current antidiabetic treatment with combination of three or more oral antidiabetic drugs

• Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)

• Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator

• Known or suspected allergy to trial product or related products

• Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures

• Receipt of any investigational drug within 4 weeks prior to this trial

• Previous participation in this trial