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Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01520831
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: biphasic insulin aspart 30 Drug: biphasic insulin aspart 50 Drug: biphasic insulin aspart 70 Drug: insulin aspart Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Four-period Cross-over Trial in Healthy Subjects, Investigating the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Soluble Insulin Aspart
Study Start Date : April 1999
Actual Primary Completion Date : May 2000
Actual Study Completion Date : May 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: BIAsp 30 Drug: biphasic insulin aspart 30
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
Experimental: BIAsp 50 Drug: biphasic insulin aspart 50
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
Experimental: BIAsp 70 Drug: biphasic insulin aspart 70
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
Active Comparator: Insulin aspart Drug: insulin aspart
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days



Primary Outcome Measures :
  1. Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes

Secondary Outcome Measures :
  1. Maximum GIR value
  2. Time to maximum GIR value
  3. Area under the GIR profile
  4. Cmax, maximum insulin aspart concentration
  5. Area under the insulin aspart concentration curve
  6. tmax, the time to maximum insulin aspart concentration
  7. t½, terminal half-life


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index between 18 and 28 kg/m^2 inclusive
  • HbA1c within the normal laboratory range
  • Non smoker for at least three months
  • Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods

Exclusion Criteria:

  • Subjects who have received any investigational drug in the 3 months prior to the start of dosing
  • Any disease requiring regular use of non topical prescription medicines
  • Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
  • Any intercurrent illness or endocrine disorders that may affect blood glucose
  • Subject with a history of drug or alcohol dependence
  • Subject with a first degree relative with diabetes mellitus
  • Subject with a history of clinically relevant allergic reactions to medical products
  • Subjects who have donated any blood or plasma in the past 3 month preceding screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520831


Locations
Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Heise T, Kapitza C, Jacobsen LV, Brøndsted L, Heinemann L. Pharmacokinetic and pharmacodynamic differences between premixed suspensions of insulin aspart: biphasic insulin aspart 30, 50 and 70. Diabetologia 2005; 48 (Suppl. 1): A301

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01520831     History of Changes
Other Study ID Numbers: BIASP-1086
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs