Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2001-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30 (NN-X14Mix30) and biphasic insulin aspart 50 (NN-X14Mix5050) in subjects with type 2 diabetes.

• Phase: Phase 1
• 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

• Duration of diabetes for at least 1 year

• Body Mass Index (BMI) maximum 30.0 kg/m^2

• HbA1c maximum 10.0%

Exclusion Criteria:

• Recurrent severe hypoglycaemia

• Proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks

• Impaired hepatic function

• Impaired renal function

• Cardiac problems

• Uncontrolled treated / untreated hypertension

• Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive

• Total daily insulin dose exceeding 40 IU

• Treatment with OHAs (oral hypoglycaemic agents) or insulin preparations twice or more frequently a day

• Treatment with OHAs or insulin preparations once a day later than noon

• Subjects who smoke more than 15 cigarettes per day