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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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