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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 30

Study type: Interventional

Funder types: Industry

Identifiers

NCT01620424

BIASP-1356

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups

Dosing visit 1

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 50

Dosing visit 2

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 50