Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

NCT ID: NCT01707160

Last Updated: 2017-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-11-30

Study Completion Date

1995-12-31

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.

Detailed Description

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Conditions

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Diabetes Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment period 1

Group Type EXPERIMENTAL

biphasic insulin aspart 30

Intervention Type DRUG

One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

biphasic human insulin 30

Intervention Type DRUG

One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

Treatment period 2

Group Type ACTIVE_COMPARATOR

biphasic insulin aspart 30

Intervention Type DRUG

One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

biphasic human insulin 30

Intervention Type DRUG

One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

Interventions

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biphasic insulin aspart 30

One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

Intervention Type DRUG

biphasic human insulin 30

One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Non-smokers
* BMI (body mass index) maximum 27 kg/m\^2
* HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%
* FBG (fasting blood glucose) maximum 6.0 mmol/L
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR,1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Jacobsen LV, Sogaard B, Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol. 2000 Aug;56(5):399-403. doi: 10.1007/s002280000159.

Reference Type RESULT
PMID: 11009049 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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ANA/DCD/031

Identifier Type: -

Identifier Source: org_study_id

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